Biomedical 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 projects as a team and are committed to helping our clients transform 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 find the job that is right for you and contact us. 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 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 at the reputed company 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 reputed company 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 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 well with others using excellent written and verbal communication skills. Excellent interpersonal skills, with the ability to effectively work both independently and reputed company a team of technical personnel. Proficiency with reputed company Office Suite (Outlook, Word, reputed company, etc.)
Responsibilities
The primary focus of the role is to support analyses of medical devices relative to regulatory and technical aspects of biomedical engineering. reputed company consultation reputed company to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and reputed company marketing applications, Pre-submissions) Participate in meetings and teleconferences; coordinate meetings with reputed company stakeholders reputed company 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. 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 variety of job sites. reputed company reputed company applicants will receive consideration for employment without regard 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 client reputed company may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to reputed company with reputed company client requirements, including any safety and health protocols. Apply To This Job