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MEDICAL DEVICE MECHANICAL ENGINEER / SUBJECT MATTER EXPERT

Cardiovascular Devices - Durability, Fatigue, Mechanical Testing, and FEA

Date: August 2026
Organization: Office of Science and Engineering Laboratories (OSEL)
Focus: Cardiovascular Device Mechanical Engineering
Location: 100% Telework
Schedule: Full-Time, Monday-Friday

Position Summary

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:

FDA Regulations and Guidance

• 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.

Risk Management

• 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.

Cardiovascular Device and Mechanical Testing Standards

The candidate should be familiar with applicable standards within the following areas, as appropriate to the device under review:

• 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 testing conducted to those standards adequately addresses relevant safety and performance risks.

Required 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.

Preferred Experience

• Cardiovascular implantable or interventional devices.
• Fatigue-life prediction and accelerated durability testing.
• Cardiovascular device mechanical testing and simulated-use testing.
• Finite element analysis of cardiovascular devices.
• Model verification and validation and correlation with experimental data.
• Fracture mechanics and mechanical failure analysis.
• Medical device risk management in accordance with ISO 14971.
• Application of ASTM, ISO, AAMI, and other FDA-recognized consensus standards.
• Direct experience supporting FDA regulatory reviews.

Education

An advanced degree (MS or PhD) in mechanical engineering, biomedical engineering, biomechanics, materials engineering, or a related field is strongly preferred.

Expected Deliverables

The SME will provide timely and technically rigorous:

• Mechanical engineering consultation reviews.
• Durability and fatigue-life assessments.
• Mechanical and accelerated durability test evaluations.
• FEA and computational modeling assessments.
• Technical reviews and regulatory recommendations.
• Identification of technical deficiencies and additional information requests.
• Written memoranda, reports, and correspondence.
• Technical support during interdisciplinary regulatory review meetings.

Position Objective

The primary objective of this position is to provide specialized mechanical engineering expertise to support the scientific and regulatory evaluation of cardiovascular medical devices. The SME will apply expertise in durability, fatigue life, mechanical testing, FEA, risk management, and applicable FDA-recognized consensus standards to assess device safety, performance, structural integrity, and reliability and to provide scientifically sound recommendations supporting timely, consistent, and risk-based regulatory decision-making.

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