Medical Device Mechanical/Chemical Engineer (Cardiovascular Device)

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 or chemical 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 should have appropriate training and experience necessary to provide effective consulting support in medical devices areas such as but not limited to shear stress evaluation, flow optimization, and standardized safety testing (i.e. ISO 10993-4). 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

• Bachelor’s degree (BS) in engineering, or a related field
• 10 years of experience (direct experience in medical device mechanical or chemical engineering)
• General knowledge and experience with a variety of medical device development technical disciplines
• Expertise in the areas of hemolysis, hemocompatibility, and fluid mechanics testing for cardiovascular devices is required.
• 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 US Citizen or full Green Card holder.

Nice To Haves

• An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
• Specific experience with the following device types is strongly recommended: ventricular assist devices, mechanical heart valves.

Responsibilities

• The primary focus of the role is to support analyses of cardiovascular medical devices relative to regulatory and technical aspects of mechanical/chemical 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: Senior