Mechanical Engineer

Mechanical Engineer – Class III Implantable Medical Devices Position Overview Mid-level mechanical engineer responsible for the full-lifecycle design and development of implantable neuromodulation systems and external accessories. This role combines hands‑on engineering execution with cross-functional collaboration and technical influence. Core Technical Responsibilities Design mechanical components, assemblies, prototypes, and test fixtures for implantable and external system components Perform solid modeling, tolerance stack analysis, and GD&T-based mechanical design Conduct FEA, fatigue testing, and mechanical experiments including test method definition and data analysis Investigate failure modes and drive design changes through structured problem solving Develop and maintain mechanical requirements, specifications, and system‑level constraints Interface with vendors on prototyping, manufacturability, and fabrication optimization Support V&V strategy and execution for mechanical subsystems Prepare and maintain engineering documentation (ECOs, design files, reports) per quality system requirements Contribute to risk management documentation including hazard analysis and FMEA Evaluate new materials, manufacturing processes, and design methodologies for feasibility Required Technical Background BS + 3–5 years of mechanical engineering experience in medical device development or verification Experience in a regulated industry; Class III medical device experience strongly preferred Expertise in tolerance stack analysis, solid modeling, and GD&T Experience designing implantable devices including lead design, polymer cast headers, feedthroughs, and hermetic sealing Familiarity with plastic injection molding, welding, and manufacturing methods specific to implantable devices Experience with usability studies and translating clinical/cadaver study feedback into design requirements FEA, fatigue testing, and biomedical materials experience preferred Lead cross‑functional project teams toward mechanical solutions aligned with program goals Influence product architecture, material selection, and manufacturing strategy decisions Proactively identify mechanical risks and guide mitigation Collaborate with systems, electrical, firmware, manufacturing, quality, and regulatory teams Communicate directly with physicians and clinicians to gather and integrate user feedback Additional Requirements Self‑directed with strong analytical and problem‑solving skills Strong communication and presentation skills; ability to influence cross‑functional decisions Able to thrive in a fast‑paced, multidisciplinary environment Approximately 10% domestic and international travel required #J-18808-Ljbffr