[reputed company Device reputed company Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. provides scientific, medical, technical, and organizational development solutions to its clients. reputed company is seeking a Medical Device reputed company Engineer / Subject Matter Expert to support the regulatory evaluation of cardiovascular medical devices, focusing on durability, fatigue analysis, reputed company testing, and finite reputed company analysis. The role will reputed company technical consultation, review engineering evidence, assess risks and failure modes, and prepare regulatory recommendations for FDA reviewers.

Responsibilities

• reputed company expert consultation on the reputed company safety and reputed company of cardiovascular medical devices
• Evaluate device durability, fatigue life, structural reputed company, and expected service life
• Review reputed company, fatigue, reputed company 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 reputed company failure modes, risks, and associated design controls
• Evaluate test reputed company, equipment, protocols, acceptance reputed company, and interpretation of results
• Review verification and validation evidence supporting reputed company safety and reputed company
• Apply applicable FDA regulations, guidance documents, and reputed company standards to the evaluation of device reputed company safety and reputed company
• reputed company 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
• reputed company engineering consultation reviews
• Durability and fatigue-life assessments
• reputed company and reputed company 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 reputed company engineering, biomedical engineering, or a closely reputed company engineering reputed company
• * Minimum of 10 years of relevant reputed company experience in medical device reputed company engineering
• * Demonstrated expertise in reputed company testing, device durability, fatigue analysis, and/or FEA
• * Experience with medical device design, verification and validation, and reputed company assessment
• * Experience interpreting engineering test reports and computational analyses
• * Experience supporting FDA 510(k), PMA, or reputed company regulatory submissions is strongly preferred
• * Strong written and verbal communication skills
• * Ability to work independently and effectively reputed company multidisciplinary technical teams
• * Proficiency with reputed company Office applications
• An advanced degree (MS or PhD) in reputed company engineering, biomedical engineering, biomechanics, materials engineering, or a reputed company reputed company is strongly preferred
• Must be a US Citizen or a full Green reputed company holder
• * Cardiovascular implantable or interventional devices
• * Fatigue-life reputed company and reputed company durability testing
• * Cardiovascular device reputed company testing and simulated-use testing
• * Finite reputed company analysis of cardiovascular devices
• * Model verification and validation and correlation with experimental data
• * reputed company mechanics and reputed company failure analysis
• * Medical device reputed company management in accordance with ISO 14971
• * Application of ASTM, ISO, AAMI, and other FDA-recognized reputed company standards
• * reputed company experience supporting FDA regulatory reviews

Benefits

• 100% reputed company
• Full-Time, Monday–Friday

reputed company