Medical Device Mechanical Engineer

Medical Device Mechanical Engineer

Bethesda, MD

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, PMAs, De Novo requests, IDEs, EUAs, combination products, and Pre-Submissions, as applicable.

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.

Major Responsibilities

• 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.

Relevant Regulations, Guidances, and Standards

The candidate should have demonstrated familiarity with applicable FDA regulations, guidance documents, and FDA-recognized consensus standards, including, as appropriate:

• 21 CFR Part 820 – Quality System Regulation, as applicable to device design and manufacturing controls.
• FDA guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.
• FDA guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review.
• FDA guidance and regulatory principles concerning design controls, verification and validation, and risk management.
• FDA-recognized consensus standards applicable to cardiovascular medical devices, mechanical safety, durability, fatigue, and performance testing.
• ANSI/AAMI/ISO 14971 – Medical Devices – Application of Risk Management to Medical Devices, including evaluation of mechanical hazards, failure modes, risk controls, and residual risk.
• ASTM F2503 – Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, where applicable.
• ASTM F2477 – Standard Test Methods for in vitro Pulsatile Strength Testing of Vascular Stents, as applicable.
• ASTM F2606 – Standard Guide for Three-Point Bending of Balloon Expandable and Self-Expanding Stents and Stent Systems, as applicable.
• ASTM F2942 – Standard Guide for Care and Use of Medical Device Testing Equipment, as applicable.
• Applicable ASTM, ISO, and AAMI standards addressing cardiovascular implants, vascular devices, mechanical properties, fatigue, durability, materials, and simulated-use testing.
• Applicable device-specific FDA-recognized consensus standards for cardiovascular implants and interventional devices.

The candidate should be capable of determining whether the standards selected by an applicant are appropriate for the device and intended use and whether…