[Hiring] Medical Device Mechanical Engineer @Tunnell Government Services

Role Description

OSEL seeks a highly qualified Medical Device Mechanical Engineer to provide subject matter expertise supporting the regulatory review of cardiovascular medical devices. The primary focus of this position is device durability, mechanical testing, fatigue-life assessment, and finite element analysis (FEA).

The successful candidate will provide scientific and engineering consultation to OPEQ reviewers evaluating premarket submissions, including:

• 510(k)s
• PMA
• De Novo requests
• IDE
• EUA
• Combination products
• Pre-Submissions

The candidate will apply expertise in mechanical engineering, computational modeling, testing, materials, and risk assessment to evaluate device design, structural integrity, mechanical performance, durability, and potential failure modes. The individual will review and interpret mechanical test reports, fatigue analyses, durability testing, FEA models, and supporting verification and validation data.

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering, or a closely related engineering field.
• Minimum of 10 years of relevant professional experience in medical device mechanical engineering.
• Demonstrated expertise in mechanical testing, device durability, fatigue analysis, and/or FEA.
• Experience with medical device design, verification and validation, and risk assessment.
• Experience interpreting engineering test reports and computational analyses.
• Experience supporting FDA 510(k), PMA, or related regulatory submissions is strongly preferred.
• Strong written and verbal communication skills.
• Ability to work independently and effectively within multidisciplinary technical teams.
• Proficiency with Microsoft Office applications.

Requirements

• Provide expert consultation on the mechanical safety and performance of cardiovascular medical devices.
• Evaluate device durability, fatigue life, structural integrity, and expected service life.
• Review mechanical, fatigue, accelerated durability, and simulated-use testing plans and reports.
• Evaluate FEA and other computational modeling, including model assumptions, material properties, boundary conditions, loading conditions, results, and validation.
• Assess mechanical failure modes, risks, and associated design controls.
• Evaluate test methods, equipment, protocols, acceptance criteria, and interpretation of results.
• Review verification and validation evidence supporting mechanical safety and performance.
• Apply applicable FDA regulations, guidance documents, and consensus standards to the evaluation of device mechanical safety and performance.
• Provide technical recommendations concerning the adequacy of submitted engineering evidence and identify deficiencies or additional information needed.
• Prepare technical reviews, consultation memoranda, regulatory comments, correspondence, and recommendations.
• Participate in multidisciplinary meetings and collaborate with FDA engineers, scientists, clinicians, and regulatory reviewers.

Benefits

• Must be a US Citizen or a full Green Card holder.
• Tunnell strives to hire and retain the most qualified talent.
• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.