Medical Device Mechanical Engineer

Tunnell Government Services • Bethesda, MD

14h • Remote

About The Position

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.

Requirements

• The candidate must possess a bachelor’s degree (BS) in engineering, computer engineering, or a related field
• 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.)
• Must be a United States Citizen or a Full Green Card holder.

Nice To Haves

• An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees