Medical Device Mechanical Engineer

Tunnell Government Services•Bethesda, MD

3d•Remote

About The Position

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.

Requirements

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.
Strong written and verbal communication skills.
Ability to work independently and effectively within multidisciplinary technical teams.
Proficiency with Microsoft Office applications.
Must be a US Citizen or a full Green Card holder.

Nice To Haves

Experience supporting FDA 510(k), PMA, or related regulatory submissions is strongly preferred.
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.
An advanced degree (MS or PhD) in mechanical engineering, biomedical engineering, biomechanics, materials engineering, or a related field is strongly preferred.

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.