[Hiring] Medical Device Mechanical Engineer @Tunnell Government Services

Role Description

The successful candidate will be an Engineer and Medical Device subject matter expert, with extensive experience involving device mechanical engineering. They will provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices, with specific attention to premarket submissions that include mechanical functions. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc.

• Expertise in analyzing key components of the regulatory approach to assess device risk to patients and users.
• Familiarity with device design and modeling, analysis and simulation, material selection, prototyping and testing, manufacturing, documentation, and human factors/ergonomics.
• Knowledge of applicable industry standards and regulatory requirements, including FDA Guidances and US regulatory standards.
• Experience in design and analysis of medical device systems, and performance of standardized device testing approaches.
• Preparation of test plans and reporting of results.

Qualifications

• Bachelor’s degree (BS) in engineering, computer engineering, or a related field.
• Advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
• 10 years of experience required (direct experience in medical device software and/or mechanical engineering).
• 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 independently and within a team.
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.).

Requirements

• Support analyses of medical devices relative to regulatory and technical aspects of mechanical engineering.
• 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.
• Must be a United States Citizen or a Full Green Card holder.

Company Description

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.