Job Summary:
We are seeking a highly experienced Senior Research and Development Mechanical Engineer to provide technical leadership for sustaining complex Class II and Class III medical devices. The role will focus on product design, verification and validation, technical investigations, reliability improvement, and lifecycle engineering. This position requires extensive collaboration across Research and Development, Quality, Regulatory, Manufacturing, Operations, and Supplier teams.

Key Responsibilities:

• Provide technical leadership across sustaining engineering initiatives involving Class II and Class III medical devices.
• Lead complex technical investigations involving product performance, complaints, CAPAs, nonconformances, and field issues using structured root cause analysis.
• Research, develop, test, and sustain mechanical and electromechanical systems for cardiovascular and other complex medical devices.
• Drive cross-functional product, process, and reliability improvements throughout the product lifecycle.
• Apply experimental, analytical, empirical, and numerical methods to evaluate product performance and investigate failures.
• Develop test strategies, methods, and protocols for system, subsystem, and component verification.
• Design, develop, qualify, and validate equipment and fixtures used for verification, reliability testing, and failure analysis.
• Identify technical risks and drive appropriate mitigation strategies.
• Analyze complaint, post-market surveillance, manufacturing, and reliability data to identify trends and improvement opportunities.
• Create and review engineering drawings and specifications for dimensioning, tolerancing, manufacturability, and assembly.
• Perform tolerance analysis and engineering stack-ups to evaluate product robustness and manufacturability.
• Apply expertise in Geometric Dimensioning and Tolerancing and mechanical system design.
• Support design reviews and provide technical guidance and mentoring to engineers.
• Evaluate manufacturing processes including precision machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly.
• Support supplier qualification and technical evaluations covering manufacturing capability, process controls, capacity, and quality systems.
• Collaborate with Quality and Regulatory teams to support submissions, audits, inspections, and regulatory inquiries.
• • Ensure compliance with applicable medical device regulations, international standards, Quality Management System requirements, and internal procedures.

Required Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
• 15+ years of progressively increasing engineering responsibility supporting Class II and/or Class III medical devices.
• Extensive experience with product development, sustaining engineering, verification and validation, manufacturing support, and risk management.
• Demonstrated technical leadership of complex cross-functional programs.
• Strong knowledge of FDA Design Controls, 21 CFR Part 820, product lifecycle management, and medical device development processes.
• Experience leading complex technical investigations and root cause analysis.
• Expertise in mechanical design, tolerance analysis, Geometric Dimensioning and Tolerancing, materials, manufacturing processes, and assembly methods.
• Experience with risk management methodologies, including Failure Modes and Effects Analysis.
• Strong written, verbal, presentation, and technical communication skills.
• Ability to communicate effectively with engineering teams, management, auditors, regulators, suppliers, and customers.
• Ability to travel approximately 10%, including domestic and occasional international travel.

Preferred Qualifications:

• Master's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Experience with ventricular assist devices, extracorporeal blood pumps, oxygenators, cardiovascular implants, or other implantable Class III medical devices.
• Experience supporting post-market surveillance, complaint investigations, CAPAs, and product reliability initiatives.
• Experience with reliability engineering, accelerated life testing, fatigue analysis, and statistical data analysis.
• Experience in medium-to-high-volume medical device manufacturing environments.
• Experience with CAD systems, Design of Experiments, Statistical Process Control, Six Sigma, and project management methodologies.
• Knowledge of ISO 13485, ISO 14971, and EU Medical Device Regulation.
• Experience working with external manufacturing partners and global suppliers.
• Exposure to multidisciplinary engineering involving electrical systems, software-controlled devices, polymers, biomaterials, and biological systems.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $60/hr to $80/hr