General Engineer

April 2026

General Engineer SME Position Description

The successful candidate will be an Engineer, with broad experience in aspects of the discipline that are relevant to the medical device domain, e.g., safety testing, design, and manufacturing, 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 experience as a systems engineer or product development engineer, as relevant to medical devices.  Expertise in areas of requirements and design input, risk management, verification and validation, cross-functional coordination, quality and documentation should be evident. 

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 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 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 US Citizen or a full Green Card holder.