[Hiring] Medical Device Engineer or Materials Scientist (Implantable Device Degradation) @Tunnell Government Services

Role Description

The successful candidate will be either an Engineer (Biomedical, Chemical, Mechanical) or Materials Scientist and Medical Device subject matter expert, with extensive experience involving degradation (fretting, wear, and corrosion) of implantable medical devices.

• Provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices.
• Focus on premarket submissions that include mechanical functions, such as:
  • Premarket Notification (510(k))
  • Premarket Approval Application (PMA)
• Analyze key components of the regulatory approach to assess device risk to a patient, user, or others in the environment of use, including:
  • Device design and modeling
  • Analysis and simulation
  • Material selection
  • Prototyping and testing
  • Manufacturing
  • Documentation
  • Human factors/ergonomics
• Familiarity with applicable industry standards and regulatory requirements, such as:
  • FDA Guidances (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices)
  • US regulatory standards (21 CFR Part 820 -- Quality System Regulation)
  • ANSI standards (ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices)
• Act as a subject matter expert on matters pertaining to medical device basic safety and essential performance.
• Experience involving the design and analysis of medical device systems and performance of standardized device testing approaches in support of regulatory approval.
• Provide effective consulting support in medical devices areas such as:
  • Shear stress evaluation
  • Flow optimization
  • Standardized safety testing (i.e. ISO 10993-4)
• Knowledge of applicable standards, testing procedures, testing equipment, verification and validation of methods, preparation of test plans, and reporting of results.

Qualifications

• Advanced degree (MS, PhD) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or equivalent.
• Specific, demonstrable expertise and experience involving degradation (fretting, wear, corrosion) of implantable medical devices, preferably orthopedic and cardiovascular implants.
• Prior work experience and/or publications in peer-reviewed sources necessary to demonstrate qualifications.
• Experience with mechanical and chemical performance testing of orthopedic and cardiovascular medical device implants.
• 10 years of experience required (direct experience in medical device engineering and/or materials science).
• General knowledge and experience with a variety of medical device development technical disciplines.
• Experience with directly supporting FDA 510(k) and related regulatory submissions.
• Exceptionally strong written and verbal communication skills.
• Excellent interpersonal skills, with the ability to work both independently and within a team of technical personnel.
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.).

Responsibilities

• Support analyses of medical device degradation relative to regulatory and technical aspects of mechanical/chemical engineering or materials science.
• Provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and De Novo marketing applications, Pre-submissions).
• Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders.
• Develop written reviews and correspondence.
• Write detailed documents and reports.

Job Type

• Full Time Employee

Schedule

• Monday through Friday (No Holidays)

Location

• This position is 100% telework.

Additional Information

• Must be US Citizen or full Green Card holder.
• Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business.
• To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.