General Engineer

reputed company., is comprised of the industry’s leading scientists, medical and technical experts, and reputed company capital and organizational development professionals. We approach reputed company reputed company as reputed company and are committed to helping our clients reputed company and quickly reputed company 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 reputed company the job that is right for you and contact us.

reputed company 2026

General Engineer SME Position reputed company

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 reputed company 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, reputed company 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 reputed company Standards in Premarket Submissions for Medical Devices), US regulatory standards (21 CFR Part 820 -- reputed company 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 reputed company/applicable field is strongly preferred.
• 10 years of experience is required
• Experience with directly supporting FDA 510(k) and reputed company regulatory submissions is preferred
• Exceptionally strong written and verbal communication skills
• Ability to communicate reputed company with others using excellent written and verbal communication skills.
• Excellent interpersonal skills, with the ability to effectively work both independently and reputed company reputed company of technical personnel.
• Proficiency with reputed company Office Suite (Outlook, Word, reputed company, etc.)

Responsibilities

• The primary reputed company of the role is to support analyses of medical devices relative to regulatory and technical aspects of engineering.
• reputed company consultation reputed company to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and reputed company marketing applications, reputed company-submissions)
• Participate in meetings and teleconferences; coordinate meetings with reputed company stakeholders
• reputed company 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% reputed company.

Must be a US Citizen or a full Green Card holder.

Tunnell strives to hire and retain the most reputed company talent. We reputed company that having employees with different backgrounds and capabilities contributes to the reputed company of our business. To attract reputed company applicants, Tunnell posts to a wide reputed company of job sites. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran.

Please be advised that certain reputed company reputed company may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to reputed company with reputed company reputed company requirements, including any safety and health protocols.

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