Medical Device Mechanical Engineer

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.


Medical Device Mechanical Engineer SME Position 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.
The candidate should possess expertise and/or direct experience enabling the competent analysis of key components of the regulatory approach to assess device risk to a patient, a user of a device, or others in the environment of use. These include, but are not limited to analysis of aspects such as device design and modeling, analysis and simulation, material selection, prototyping and testing, manufacturing, documentation, and human factors/ergonomics.
The candidate should be familiar with applicable industry standards and regulatory requirements, such as, but not limited to, FDA Guidances (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices), US regulatory standards (21 CFR Part 820 -- Quality System Regulation), and ANSI standards (ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices).
The candidate should also possess expertise, and/or direct experience enabling them to act as a subject matter expert on matters pertaining to medical device basic safety and essential performance. The candidate should also have experience involving the design and analysis of medical device systems, and performance of, and interpretation of results produced through standardized device testing approaches, in support of regulatory approval. The candidate’s experience should include knowledge of applicable standards, testing procedures, testing equipment, verification and validation of methods, preparation of test plans, reporting of results.
Qualifications

The candidate must possess a bachelor’s degree (BS) in engineering, computer engineering, or a related field
An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
10 years of experience is 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
Ability to communicate well with others using excellent written and verbal communication skills.
Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Responsibilities

The primary focus of the role is to 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.

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.

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