Biomedical Engineer SME Position Description

The successful candidate will be a Biomedical Engineer, with broad experience in aspects of the discipline that are relevant to the medical device domain, e.g., design, development, refinement, etc. 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. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc.

The candidate should have demonstrated at the interface of advanced engineering and clinical medicine. Expertise in areas of research and development, quality and regulatory affairs, manufacturing and production, and clinical evaluation and field support should be evident. Additional specialization in relevant areas, such as biomaterials, biomechanics, bioinstrumentation, is desired.

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).

Qualifications

• The candidate must possess a bachelor's degree (BS) in biomedical engineering.
• An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
• 10 years of experience is required
• Experience with directly supporting FDA 510(k) and related regulatory submissions is preferred
• 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 biomedical 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

Must be a US Citizen or Full Green Card holder.

Job Type: Full Time Employee

Schedule: Monday through Friday (No Holidays)

Location: This position is 100% telework.

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.