Careers

Home > Careers

Careers Banner

A Progressive and Exciting Workplace

At Acumed, the people who work here are our most valuable asset. By providing a dynamic environment that supports individual growth and responsibility, we’ve been able to hire, and retain some of the brightest minds in healthcare. We believe strongly that each of our employees makes an impact on the lives of the patients who receive our products. Which is why we encourage everyone within the company to push the limits of their expertise, whether it’s in engineering, production, inspection, marketing, or regulatory and compliance. Personal health and happiness are highly valued at Acumed, and we devote a significant amount of resources to ensure it. We provide benefits that enhance medical care, help plan for the future and promote general well being.


Acumed is currently hiring for a variety of positions. To apply for an open position, please visit our careers portal.

Benefits Include . . .

  • Generous PTO
  • Medical, Dental, and Life Insurance
  • Short and Long Term Disability Insurance
  • 401(k)
  • Nine Paid Holidays
  • Retirement Plan
  • Flexible Spending Accounts
  • Educational Assistance
  • TriMet Bus Passes
  • Reduced Costco Membership Fees
  • Reduced Gym Membership Fees
  • An Employee Referral Program
  • Bike Room and Showers

Current Open Positions

Position Location Department Posted Onsort descending
Sales Trainer Hillsboro, OR, USA Medical Education Sep. 01, 2014

Job Purpose/Scope
The Sales Trainer conducts a wide range of training engagements including on-site and in-field sales training courses. Sales training courses will incorporate classroom, live video, and taped webinar sales support detailing effective sales techniques focused on Acumed’s strategic sales initiatives. Additionally, the Sales Trainer will provide the field sales organization learning outcomes driven by integrating sales methodologies, increasing market penetration, developing selling acumen, competitive insights, and product sales advantages to create confidence and excitement in choosing Acumed orthopaedic solutions. This position will support the Medical Education and Training Team Manager in the creation and execution of sales training and development plan.

General Duties/Responsibilities

  • Creates and delivers sales training content to the Acumed field sales organization focused on increasing product placement and selling skills.
  • Regularly assesses the sale force training needs by observing individual account manager’s performance/ behaviors and collaborates with the Medical Education and Training leadership to mitigate these needs.
  • Participates in strategic projects designed to fulfill the needs of the field Sales Force. These projects include continuous collaboration with all relevant support departments: Marketing, Regulatory, Product Management, Sales and include but are not limited to new product launches, new marketing directives, new indication launches and new positioning directives.
  • Analyzes and assesses sales training effectiveness to determine when revisions, enhancements, or new programs should occur and receives recommendation/input from team. Provides input to Medical Education and Training leadership.
  • Reviews department reports, sales trainee evaluations to evaluate the effectiveness of training feedback. Initiates continuous improvement plan based in response to this feedback.
  • Develops evaluations to measure training effectiveness and provide metrics for management review.
  • Acts as main point of contact for day to day operations related to development of new training initiatives or supporting changes in direction.
  • Oversee and manage on-site cadaveric lab usage. Implement business plan for leveraging the cad lab’s strategic future in sales training and other sales interests.

 

Qualifications

  • Minimum BS/BA/RN degree
  • 5+ years orthopaedic/healthcare commercial experience in sales, marketing, training, or related experience
  • 2+ years of orthopaedic training/teaching experience
  • Ability to develop/facilitate training classes/workshops
  • Excellent communication/presentation skills (both oral and written)
  • Demonstrated ability to work effectively both independently or in a team
  • Proficiency with Microsoft Office software (e.g. Power Point, Word, Excel)
  • Excellent planning and organization skills
  • Solid understanding of Acumed products and their surgical applications
  • Discretion, confidentiality and ability to build strong, trusting relationships
  • Solid understanding of global healthcare policies, trends and compliance issues
  • Conversational Spanish language skills, preferred

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Project Manager Hillsboro, OR, USA Project Management Nov. 05, 2014

Overview

Using independent judgment, plans, manages and executes several simultaneous new product development projects from initiation through project close. Evaluates projects according to predetermined timelines and budgets. Ensures quality control throughout the project life cycle.

Duties/Responsibilities

• Lead cross-functional project teams (Product Development Teams). Facilitate communication and interaction amongst the functional representatives.
• Coordinate project priorities with cross-functional management and coordinate overall project launch logistics with Operations team.
• Coordinate and track project against schedule and budget of New Product Introduction, oversee all aspects of projects with PDTs, and ensure projects meet goals and are completed on time and within budget.
• Set deadlines, assign responsibilities, and monitor and summarize progress of projects.
• Lead the work of others assigned to projects from various departments.
• Prepare reports for upper management regarding status of projects and coordinate the preparation Acumed Product Lifecycle documentation.
• Develop and implement recovery plans when projects get off track (i.e. scope, budget, or schedule).
• Work with other Program and Project Managers to continuously improve NPI processes to make product development and launches more efficient and provide visibility across teams of project needs, conflicts, and constraints.
• Ensure any risks and issues that may impact the schedule are identified and resolved quickly, and are escalated to the appropriate stakeholders if there will be an impact to the scope, schedule, or budget. Provide options for mitigating impact.


Qualifications

• Bachelor's degree required with a preference for a BS degree in Mechanical, Manufacturing, Industrial Engineering or related field.
• 3-5 years of experience of medium to large complex project management in product development and/or manufacturing.
• CAMP (Certified Associate in Project Management) and /or PMP (Project Management Professional) preferred.
• Experience with MS Project (or equivalent project management software) to manage project schedule, tasks, and resources.
• SAP experience highly desirable.
• Familiar with standard concepts, practices, and procedures in the medical device field or related area preferred.
• General knowledge of finance, including ability to read and understand financial data such as product income statements, return on investment analysis.
• General knowledge of marketing, including market research, sizing, pricing, marketing communications and product launch.
• A wide degree of creativity and latitude is expected and excellent communication skills, both written and oral are required.
• Solid interpersonal skills to interface with co-workers, customers and vendors at all levels.
• Ability to manage specific tasks to completion with minimal direction.
• Demonstrated ability to mentor, develop and influence others.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Corporate Account Executive Hillsboro, OR, USA Major Accounts Nov. 11, 2014

Overview
Utilizes a wide array of analytical, interpersonal, and critical thinking skills to develop and maintain strong working relationships with administrative, contracting and clinical leaders at assigned accounts, presenting Acumed as the solution to their problems. Develops new business in corporate accounts, drives contract compliance in the corporate accounts, and works with the sales team to develop strategies to grow corporate account business. This is a field-based position.

General Duties
• Establish relationships with pertinent supply chain personnel, including heads of contracting and value analysis and maintain key decision maker contact lists.
• Close new business deals by coordinating requirements, responding to RFP's, developing and negotiating contracts, and integrating contract requirements with business operations.
• Act as key point of contact for Corporate Offices of assigned clinical facilities, IDNs and GPOs, supporting all contract and service related issues across the Acumed business, including:
• Act as a content expert on corporate contract portfolio of assigned accounts, supporting field teams with strategies to optimize existing agreements
• Serve as a key member of the sales team who contributes to strategic direction by developing, making recommendations and implementing account strategy with corporate accounts
• Oversee all product conversion opportunities by coordinating resources, providing analytics and reporting regularly on progress both internally and externally.
• Represent Acumed in supply chain meetings and be the conduit to the sales organization for opportunity analysis.
• Assist in the preparation and operation of customer site visits, trade shows, conventions, and/or clinical meetings
• Routinely update/engage local sales team from rep to manager on business status changes and pending strategies
• Analyze and interpret sales and trend data to develop targeted action plans

Qualifications

• BA/BS in Business or related field highly preferred, equivalency in experience required.
• 5+ years experience in medical device national accounts.
• Strong negotiation and sales skills.
• Ability to determine which company resources are needed to effectively win selected national account contracts and effectively facilitate and coordinate those resources as required.
• Strong interpersonal and relationship management skills, demonstrated ability to interact with other professionals to gather and disseminate information.
• Strong attention to detail, tolerance for time sensitive deadlines and the ability to manage multiple priorities.
• Proven track record in prospecting and relationship development with IDNs, GPOs, etc.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior Quality Engineer Hillsboro, OR, USA Quality Nov. 11, 2014

Job Purpose/Scope

This position has the responsibility and authority to provide Quality Assurance Engineering representation to Product Development teams. This position owns the risk management profile for products during their entire lifecycle, including risk identification, completion, and management of risk mitigation activities. Participates in facilitation of initial product design, development, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to organization for use in business decisions. Partner with Operations and Engineering in process improvements.
Responsible for quality planning and the overall quality of new products being released to the market through participation in product development to ensure product and process conformance to global standards (including FDA and ISO 13485). Performs, directs, or consults in process and design validations. Provides QA approval for changes to design, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drives investigations, corrective action implementation, and corrective action verification activities as assigned.
Position is also responsible to aide in the identification, documentation and subsequent testing of all design requirements identified by all internal and external customers, including end users, purchasing organizations, and regulators.

Duties/Responsibilities
• Provide quality leadership in product development teams to the entire design lifecycle of Acumed products to ensure compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485. The design lifecycle includes design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Coordinate with Regulatory staff members to ensure that product testing and design requirements for intended markets are identified, part of the product requirements as documented in the Design History File, and met during the product development. Represent the needs of the Regulatory team during product development.
• Guide teams to ensure robust application of appropriate design and manufacturing controls.
• Educate project teams on requirements related to regulations, procedures, and requirements. Provide training, guidance and interpretation.
• Ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
• Provide ongoing quality engineering support throughout the product life cycle, including risk management, design and manufacturing changes, and CAPA investigations.
• Lead all risk management activities for products throughout their lifecycle, including risk identification, completion, and management of risk mitigation activities.
• Be a strong representative for Quality and Regulatory concerns during technical discussions and risk-based decision making; ensure issues are resolved using a risk-based approach.
• Monitor the quality and performance of new products to ensure requirements are met and product is performing as anticipated. Identify concerns, develop a risk-based solution with impacted departments and lead implementation efforts, as appropriate.
• Drive the creation and approval of verification and validation reports and identify gaps for compliance with Acumed policies and global regulations. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Deliver appropriate quality metrics to the organization to identify opportunities and drive improvements. Consult with end users and process owners on data collection, analysis and reporting.
• Identify opportunities, develop solutions, and support implementation of improvements to the design and development process. Support continuous improvement efforts.
• Report status updates on assigned responsibilities and goals; timely escalation of issues
• Other activities as assigned.

Qualifications

• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 5-7 years of experience working in quality assurance role in a regulated environment. Experience working with implantable devices preferred.
• Experience applying quality regulations and standards (e.g. 21 CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
• Experience with CAPA and failure investigation tools and techniques.
• Applied experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Knowledge of ERP Systems (SAP preferred) and advanced Microsoft Office; expert level Microsoft Excel skills.
• Certified Quality Engineer (or equivalent) preferred.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior/Staff Packaging Engineer Hillsboro, OR, USA Engineering Nov. 17, 2014

Overview

The Packaging Engineer is responsible for packaging, product delivery and labelling solutions for medical devices from concept to commercialization. The Packaging Engineer works closely with Product Engineering, Product Management, Quality and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include implementing new packaging, product delivery solutions, maintenance of existing packaging/ product delivery solutions/ labelling, testing and validation, and effective communication with team members, management and customers.


Duties/Responsibilities
• Review draft project plans and provide feedback to ensure the plans are realistic and complete
• Research product designs, indications, intended use(s), technologies, materials.
• Create and/or develop designs for potential new product solutions and/or improved product lines, and document the design and development.
• Performs mechanical and biomechanics testing
• Create complete models, drawings, specifications, and related documents required to produce products and prototypes.
• Follows established Best Known Methods and Standards
• Conduct design verification and validation activities.
• Maintain existing solutions through championing ECO's
• Provide leadership and mentorship to junior staff including interns
• Leads small teams
• Manage multiple tasks and smaller projects
• Create draft project plans and solicit feedback to ensure the plans are realistic and complete
• Create competitive product matrices for new and/or existing product lines
• Conduct tests, write protocols and reports
• Initiates Cad Labs for internal product development
• Create new designs with moderate complexity; drawings, models, define design requirements
• Collaborates with external design partners and vendors
• Develop presentations and present clearly to internal audiences (e.g. training events)
• Communicates effectively with Sales, Field Reps, suppliers and surgeons
• Make updates/modifications to existing SOP's/ Work Instructions
• Perform Design Control activities with some supervision
• Write clinical data reports
• Review and approve drawings in ECOs
• Support Regulatory with 510(k) and Technical File support documents
• Perform market analyses, work with Product Management on ROIs
• Interfaces with manufacturing, quality, planning, regulatory, and other departments on a regular basis to determine feasibility of new project ideas/concepts/designs.
• Act as independent reviewer on other projects
• Conduct patent analyses
• Performs complex mechanical / biomechanical analyses (ex: Finite Element Analysis, etc.)
• Create designs with significant complexity
• Develop presentations and present to external audiences
• Communicates effectively and forms relationships/collaborates with Surgeons/providers/consultants/Suppliers
• Develop/refine Acumed processes (SOPs, Work Instructions, etc.)

Qualifications

• Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent
• 3-5yrs applicable experience and demonstrated ability to perform applicable job duties
• Competency in communicating anatomy/physiology (A/P)
• Proficient with application of GD&T
• Thorough understanding of anatomy
• Working knowledge of FDA and ISO requirements related to medical devices
The Packaging Engineer is responsible for packaging, product delivery and labelling solutions for medical devices from concept to commercialization. The Packaging Engineer works closely with Product Engineering, Product Management, Quality and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include implementing new packaging, product delivery solutions, maintenance of existing packaging/ product delivery solutions/ labelling, testing and validation, and effective communication with team members, management and customers.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Regulatory Affairs Manager Hillsboro, OR, USA Regulatory Nov. 18, 2014

General Duties/Responsibilities
• Establishes overall strategic plan for Regulatory Affairs, and manages the execution of all efforts targeted at fulfilling strategies.
• Participates in selection of suitable third party contractors, and interfaces with Regulatory affairs to ensure ongoing quality compliance.
• Manage maintenance of required establishment listings for FDA, EU MDD and CMDCAS including renewal or changes
• Initiate and maintain accurate international product registration, including renewal or changes, and certificates for foreign governments
• Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative
• Oversee Preparation, organization, coordination of content/data and ensure regulatory compliance for submission to the FDA or regulatory agencies (e.g. 510(k), PMA, MDD Technical Files/Design Dossiers, global registration applications, etc.)
• Develops and empowers people to focus on the customer.
• Creates a strong team environment based on and supporting company values.
• Articulates vision and strategy to executive management, peers and subordinates in order to gain quality systems compliance, commitments and results.
• Helps develop annual operating budget and manages activities to achieve expected ratios.
• Responsible for the review and performance of capital expenditures to ensure expected investment benefit is achieved.


Qualifications
• BA/BS in engineering or related field. (Masters preferred)
• Minimum of 5 years leadership/management experience in regulatory environment.
• Experience in medical device manufacturing preferred.
• Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE and other international standards.
• Proven problem-solving skills and the ability to train teams to resolve various issues using available tools.
• Extensive knowledge and experience in implementation of Six Sigma quality concepts and techniques.
• Familiarity with Lean Manufacturing concepts.
• Knowledge and experience with ERP/MRP systems and their applications.
• Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Packaging Engineer Hillsboro, OR, USA Engineering Dec. 15, 2014

Job Purpose/Scope
The Packaging Engineer is responsible for packaging, product delivery and labelling solutions for medical devices from concept to commercialization. The Packaging Engineer works closely with Product Engineering, Product Management, Quality and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include implementing new packaging, product delivery solutions, maintenance of existing packaging/ product delivery solutions/ labelling, testing and validation, and effective communication with team members, management and customers.


Duties/Responsibilities
• Review draft project plans and provide feedback to ensure the plans are realistic and complete
• Research product designs, indications, intended use(s), technologies, materials.
• Create and/or develop designs for potential new product solutions and/or improved product lines, and document the design and development.
• Performs mechanical and biomechanics testing
• Create complete models, drawings, specifications, and related documents required to produce products and prototypes.
• Create draft project plans and solicit feedback to ensure the plans are realistic and complete
• Create competitive product matrices for new and/or existing product lines
• Conduct tests, write protocols and reports
• Initiates Cad Labs for internal product development
• Collaborates with external design partners and vendors


Qualifications
• Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent
• 2-5yrs applicable experience and demonstrated ability to perform applicable job duties
• Competency in communicating anatomy/physiology (A/P)
• Proficient with application of GD&T
Job Purpose/Scope

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Field Education & Training Manager, Midwest Hillsboro, OR, USA Medical Education Dec. 15, 2014

Job Purpose/Scope
The Field Education & Training Manager is an international position that works in his/her territory to run or support local medical education events and distributor product training. The Field Education & Training Manager defines his/her territory's annual strategy together with his/her dotted line manager and works with his/her direct line manager to ensure education and training is executed in a consistent, high-quality standard.

General Duties/Responsibilities
• Define territory's annual medical education and product training strategy, aligning the strategy with the needs of the territory and the strategy of the company.
• Work with direct and dotted line managers to define performance metrics for which the FE&TM is responsible for measuring and report on monthly.
• Work at tradeshows, medical education and product training events in the field or at Acumed headquarters.
• Communicate surgeon and distributor feedback to the appropriate people at Acumed.
• Continuously build knowledge of the clinical practice of orthopedic trauma and Arthroplasty, Acumed and competitive products, support product knowledge training based on educational methodologies, published research and the overall managed care environment.
• Occasionally help with account conversions, customer service, surgical coverage, etc., but only as necessary and agreed upon by direct line manager.
• Maintain full compliance with Acumed's Code of Conduct and related FDA and AdvaMed regulations.

Qualifications
• BA/BS in a related field or equivalent experience required
• 3+ years medical sales experience (with 2+ years orthopedic / trauma sales experience) or 3+ years clinical orthopedic trauma experience required
• Ability to think strategically and to contribute in a team environment
• Knowledge of healthcare industry and trends
• Strong project management and product knowledge/integration skills, , market and industry knowledge, strong business acumen and planning skills
• Ability to master product knowledge and protocols
• Exceptional communication and teamwork skills, including relationships management skills
• Ability to demonstrate proper surgical use of our product to physicians
• Proficiency in computer word-processing, spreadsheets, and database applications. (MS Office).
• Exceptional problem-solving skills
• Ability to provide a home working office

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Graphic Designer Hillsboro, OR, USA Marketing Communications Dec. 22, 2014

Job Purpose/Scope
Under minimal supervision, the graphic designer collaborates with marketing, technical staff, and outside vendors to conceptualize, design and produce visual communication solutions for brochures, training materials, presentations, tradeshow graphics and other assignments necessary. The graphic designer works closely with others in the marketing department for long-term and day-to-day projects.

Duties/Responsibilities
• Design and produce product literature, training/event materials and other marketing materials
• Prepares files for print and online formats.
• Coordinates with Events, Med Ed, Product Management, and Sales teams for effective project management.
• Coordinates with print vendors for transfer, proofing, printing and delivery of materials.
• Collaborates with internal resources and vendor to produce promotionally branded items (shirts, mugs, bags, etc.)

Qualifications
• Associates Degree in Graphic Design and 1-3 years of experience or equivalent combination of education and experience
• Required Software Skills: Adobe InDesign, Illustrator, Photoshop, MS Office
• Statements should include minimum educational and experience requirements
• Strong attention to detail
• Strong time management skills and ability to multi-task
• Ability to master new design software and tools with minimal supervision
• Ability to read and speak English sufficiently to read, understand and complete all paperwork
• Excellent verbal and written communication skills

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

International Shipping Specialist Hillsboro, OR, USA Logistics Dec. 23, 2014

Job Purpose/Scope
Under general supervision, follows established procedures to ensure international shipments and related tasks are completed daily. The Specialist will be responsible for regional customer accounts to ensure quality of service to our customers. With support from the International Shipping Lead, the Specialist will be required to maintain export regulation knowledge of their assigned customer countries and document changes.

Duties/Responsibilities
• Generate, pull and package deliveries for outbound shipments.
• Initiate and process rework orders for international shipments.
• Perform inventory movements within the warehouse.
• File and maintain shipping records; generate international shipping documentation; file export compliance documentation and communicate status of shipments to appropriate personnel as necessary.
• Perform and maintain denied party search; document and report findings.
• Maintain assigned customer account responsibilities including order management, reports, email correspondence with customers, coordination of shipping instructions and documentation with third party freight forwarders and reconciliation of clearance delays.
• Analyze shipping volumes; open customer orders and priorities to ensure on time delivery.
• Interact with international customers, couriers, freight forwarders and customs agents when necessary; ensure clearance delays are reconciled in a timely matter.
• Promptly respond to requests for freight rates.
• Perform inventory audits when necessary; document and reconcile internal and external errors as reported.
• Understand all department metrics to support and participate in process improvements.
• Support US shipping activities and may assist picking/assembly of consignment and launch sets.
• Operate and maintain Shipping equipment.

Qualifications
• High school Diploma or GED
• International shipping experience preferred
• Prior warehouse experience required
• Ability to produce results, prioritize tasks and manage time effectively, set a good example for others, project a positive, professional image at all times
• Highly detail-oriented and self-motivated with good organization skills and habits
• Provide quality service and support in a variety of areas
• Computer literacy required and experience with MS Office suite preferred (Word, Excel, Outlook)

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Sustaining Engineer Hillsboro, OR, USA Engineering Dec. 29, 2014

Job Purpose/Scope
The Sustaining Engineer is responsible for product support after product development is completed. The Sustaining Engineer works closely with Process Engineering, Development Engineering, Product Management, Quality, Regulatory and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include designing and implementing modifications to existing products and processes, testing and validation, and effective communication with team members, management and customers. Also includes establishing procedures and standards for releasing products to market and maintaining them after release.

Duties/Responsibilities
• Manage multiple tasks
• Review draft project plans and provide feedback to ensure the plans are realistic and complete
• Research product designs, indications, intended use(s), technologies, materials.
• Create and/or develop designs for potential new product solutions and/or improved product lines, and document the design and development.
• Performs mechanical and biomechanics testing
• Participates in Cadaver Labs for internal product development
• Create complete models, drawings, specifications, and related documents required to produce products and prototypes.
• Follows established Best Known Methods and Standards
• Communicate effectively with supervisor, internal departments, vendors, and customers.
• Gives presentations to small internal audiences
• Interfaces with manufacturing, quality, planning, regulatory, and other departments on a regular basis to determine feasibility of new capabilities/concepts/designs.
• Write high level documents (white papers, design rationales, technical answers etc.)
• Approve test protocols, test reports.

Qualifications
• Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent.
• Understanding of human anatomy, musculoskeletal system preferred
• Proficiency with Microsoft Office software
• Basic understanding of GD&T practices
• Working knowledge of 3D/2D software and drafting

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Regional Business Manager, Northeast Hillsboro, OR, USA Sales Jan. 09, 2015

Job Purpose/Scope
The Regional Business Manager is responsible for generating new business to ensure growth and development of an assigned region. This includes establishing strategic plans, goals and objectives for growth of sales, aligning efforts with Acumed's vision, and driving progress. This position requires a home office.

Duties/Responsibilities
• Develop strategies to increase market share.
• Examine and analyze data to forecast future marketing trends.
• Business management leadership with sales groups.
• Locate, review and analyze sales groups in order to hire those that best fit within Acumed's product distribution goals.
• Develop and maintain effective relationships with key surgeons and customers.
• Must be able to travel (fly and drive) at least weekly.
• Seek out new strategic opportunities for the company.
• Develop and maintain product line technical expertise.
• Participate in conventions, professional exhibitions and training courses to maintain company image.
• Remain aware of product requirements and new market opportunities.
• Participate in Sales Agencies Sales Meetings.
• Deliver The Acumed Mission and Values to the sales force.
• Work with targeted hospitals and healthcare professionals to provide product research updates, innovations and other key information.
• Develop and manage effective relationships with new and existing sales groups.
• Gather data on competitors and analyze market.
• Perform financial analyses and evaluation of projects.

Qualifications
• BA/BS in Business or related field required, Masters in Business Administration preferred.
• 10+ years' experience with Medical products or medical devices highly preferred with 5+ years in medical device sales management of independent agents and distributors.
• Solid understanding of region market and business practices
• Strong interpersonal and relationship management skills, demonstrated ability to interact with other professionals to gather and disseminate information.
• Demonstrated ability to handle customer product questions and objections in a way that is consistent with sales training methodology.
• Ability to demonstrate proper surgical use of our product.
• Exceptional problem-solving skills.
• Ability to think strategically and to contribute in a team environment.
• Knowledge of healthcare industry and trends.
• Understanding of business development principles involved in strategic planning, resource allocation, leadership techniques and staff development preferred
• Ability to work collaboratively and independently in a cross-functional and team oriented environment
• Strong attention to detail, tolerance for time pressure deadlines and the ability to manage multiple priorities
• Strong analytical skills and the ability to deliver results with multiple and complex projects

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Instructional Designer Hillsboro, OR, USA Medical Education Jan. 16, 2015
Overview

The Instructional Designer develops and designs curriculum and content for Medical Education and Sales Training programs for Acumed personnel and customers to promote the safe use of our products, increase product knowledge, and sales techniques. This position combines in-depth knowledge of adult learning theory and skill development, various forms of instructional media, and facilitation expertise. The Instructional Designer develops an entire curriculum from individual courses to entire programs, with multiple coursework. Keeps abreast of emerging instructional design theory, instructional technologies, and developments in technology enhanced learning tools by participating in professional development and research activities.

Duties/Responsibilities
• Develop training objectives roadmap for overall curriculum structures and develop education plans for each project. Design and implement the process for curriculum planning and course development.
• Develop project proposals including budgets, timelines as part of curriculum development process.
• Design, develop and implement e-learning and classroom training for various target audiences using appropriate writing styles to make content easy to understand.
• Create online self-paced training modules that reinforce key anatomy, procedure, and product objectives.
• Analyze learning aims and objectives and work with Subject Matter Experts (SMEs) to design solutions that align with learner and business needs. Apply instructional design theories and practice.
• Develop training on competitive product initiatives to ensure field salesforce can respond to competitive product offerings.
• Apply the instructional design process to increase productivity in existing courses. Create appropriate course interactions that support and reinforce key learning objectives.
• Solicit and analyze training requirements to ensure deliverables meet the learning objectives of the audience.
• Maintain the complete repository of training documents, to include version control and dissemination protocols, while ensuring the accuracy, availability, reliability and consistency of those documents.
• Become a subject matter expert on Acumed products to support the rapid development of training.
• Design and implement review, testing, and evaluation methods for education and
• Design and implement salesforce training effectiveness measurement tools.

Qualifications
• Bachelor's degree in Education, Clinical (R.N. RPh) or Technical area such as engineering or science required. MS in Instructional Design & Development or Education preferred
• 3 or more years of experience developing educational content for an orthopedic company, hospital clinic environment or related field
• 2 or more years combined work experience in these areas: hospital, clinical, sales or sales support, healthcare industry education
• Prior curriculum design experience required; Instructional Design & Development or Education preferred.
• Demonstrated and successful management of multiple projects.
• Excellent written and verbal communication skills.
• Must be able to read and interpret complex technical information, facilitate training, make presentations, influence leaders and staff, and listen attentively.
• Must be proficient in standard word processing, spreadsheet and presentation software (MS Office).
• Attention to detail and creativity are required.
• Online, asynchronous training development experience required.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior Regulatory Affairs Specialist Hillsboro, OR, USA Regulatory Jan. 20, 2015

Senior Regulatory Specialist
The Senior Regulatory Specialist will function as the regulatory representative in the product development process to develop and execute product strategies. The Specialist will provide training and support for internal stakeholders, external customers, and the relevant compentent authorities. In additon, the Specialist will perform local country surveillance for assigned regulatory activities. Also, the Regulatory Specialist will ensure all records and systems supporting regulation are adequately maintaned and compliant to current regulations.


Duties/Responsibilities
• Must have a self-driven ability to investigate and understand regulations. Senior-level employee that works well independently and with a team, depending on the situation requirements.
• Initiate and maintain required establishment listings for FDA, EU MDD and CMDCAS including renewal or changes
• Initiate and maintain accurate international product registration, including renewal or changes, and certificates for foreign governments
• Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative
• Prepare, organize, coordinate content/data and ensure regulatory compliance for submission to the FDA or regulatory agencies (e.g. 510(k), PMA, MDD Technical Files/Design Dossiers, global registration applications, etc.)
• Ensure all processes for the essential functions are documented in procedures
• Review and disposition ECRs/ECOs for potential impact to new and existing registrations.
• Review of all Product labeling to assure compliance with registrations.
• Assist in determination of appropriate product testing to support registration activities.
• Determine the best strategy to register new products in specific global markets


Qualifications
•  Bachelor's degree required in Regulatory Affairs, Biology, Chemistry, Engineering, or related field

• 5+ years of related experience required

• Masters of Science in Regulatory Affairs, Biology, Chemistry, Engineering or related field preferred
• Evidence of applied knowledge of applicable FDA, CMDCAS, ISO, MDD, region-specific requirements and consensus standards
• Ability to work with FDA, Notified Body, EU Authorized Representative and other global regulatory agencies
• Able to manage multiple projects simultaneously
• Proven track record of strong team work, creatively strategic thinking
• Ability to work well with others, support regulatory activities and mentor/train others
• Excellent written and verbal communication skills

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Regulatory Affairs Specialist Hillsboro, OR, USA Regulatory Jan. 20, 2015

Under general supervision, the Regulatory Specialist helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as necessary.

Duties/Responsibilities
• Understands regulations, follows complex directions, and investigates when clarification is needed.
• Initiates International product registration, including renewals or changes and certificates for foreign governments
• Manages correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, Medimark
• Prepares, organizes, and coordinates data for submission to the FDA or regulatory agencies (e.g. 510(k), MDD Technical Files, etc.)
• Participates in the preparation and execution of ISO and FDA audits
• Assures regulatory compliance and content accuracy of Technical Files and 510(k) files
• Completes the duties described in the Quality Manual
• Converts and/or approves ECRs/ECOs requiring regulatory review
• Assists in package insert (instructions for use) development, organization and application
• Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products
• Product development design review team and risk team contributor, providing regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards, codes and regulations
• Reports standards changes and summarizes impact on Acumed products
• Involvement in new country/market registration as required
• Assists in labeling (e.g. package inserts/IFUs(instructions for use), marketing materials, package labels, etc.) development, organization, application and/or review
• Assists in development of company regulatory strategies and determine priorities with Sales & Marketing, Engineering and Quality
• Reports standards changes, determines impact and takes appropriate action

Qualifications
• Bachelor of Science in Biology, Chemistry or related field required
• Knowledge of applicable FDA, CMDCAS, ISO, and MDD requirements and consensus standards
• 2 - 5+ years of regulatory experience
• Ability to support product development projects
• Experience in the medical device industry or related industry (quality, regulatory, or orthopedic engineering) is a benefit

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Regional Business Manager, Southwest Hillsboro, OR, USA Sales Jan. 23, 2015

Job Purpose/Scope
The Regional Business Manager is responsible for generating new business to ensure growth and development of an assigned region. This includes establishing strategic plans, goals and objectives for growth of sales, aligning efforts with Acumed's vision, and driving progress. This position requires a home office in the Southwest region of the US.

Duties/Responsibilities
• Develop strategies to increase market share.
• Examine and analyze data to forecast future marketing trends.
• Business management leadership with sales groups.
• Locate, review and analyze sales groups in order to hire those that best fit within Acumed's product distribution goals.
• Develop and maintain effective relationships with key surgeons and customers.
• Must be able to travel (fly and drive) at least weekly.
• Seek out new strategic opportunities for the company.
• Develop and maintain product line technical expertise.
• Participate in conventions, professional exhibitions and training courses to maintain company image.
• Remain aware of product requirements and new market opportunities.
• Participate in Sales Agencies Sales Meetings.
• Deliver The Acumed Mission and Values to the sales force.
• Work with targeted hospitals and healthcare professionals to provide product research updates, innovations and other key information.
• Develop and manage effective relationships with new and existing sales groups.
• Gather data on competitors and analyze market.
• Perform financial analyses and evaluation of projects.

Qualifications
• BA/BS in Business or related field required, Masters in Business Administration preferred.
• 10+ years' experience with Medical products or medical devices highly preferred with 5+ years in medical device sales management of independent agents and distributors.
• Solid understanding of region market and business practices
• Strong interpersonal and relationship management skills, demonstrated ability to interact with other professionals to gather and disseminate information.
• Demonstrated ability to handle customer product questions and objections in a way that is consistent with sales training methodology.
• Ability to demonstrate proper surgical use of our product.
• Exceptional problem-solving skills.
• Ability to think strategically and to contribute in a team environment.
• Knowledge of healthcare industry and trends.
• Understanding of business development principles involved in strategic planning, resource allocation, leadership techniques and staff development preferred
• Ability to work collaboratively and independently in a cross-functional and team oriented environment
• Strong attention to detail, tolerance for time pressure deadlines and the ability to manage multiple priorities
• Strong analytical skills and the ability to deliver results with multiple and complex projects

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.