Note: The job is a remote job and is open to candidates in USA. Tunnell Government Services, Inc. provides scientific, medical, technical, and organizational development solutions to its clients. The company is seeking a Medical Device Mechanical Engineer / Subject Matter Expert to support the regulatory evaluation of cardiovascular medical devices, focusing on durability, fatigue analysis, mechanical testing, and finite element analysis. The role will provide technical consultation, review engineering evidence, assess risks and failure modes, and prepare regulatory recommendations for FDA reviewers.
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
- 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
Skills
- * 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
- An advanced degree (MS or PhD) in mechanical engineering, biomedical engineering, biomechanics, materials engineering, or a related field is strongly preferred
- Must be a US Citizen or a full Green Card holder
- * 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
Benefits
- 100% Telework
- Full-Time, Monday–Friday
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