Mechanical Engineer
Core
Design, develop, and deliver high-reliability mechanical components and assemblies for Class III implantable neuromodulation systems (deep brain simulation) and associated external accessories.
Role type
Senior Mechanical Engineer (Medical Devices)
Builds
Implantable neuromodulation systems and external accessories for deep brain simulation
Domain
Medical Devices / Biomedical Engineering
Deliverable
production ML models | product features
Required skills
Solid modeling, tolerance stack analysis, GD&T, FEA, fatigue testing, biomedical materials, plastic injection molding, welding, hermetic sealing design, lead design, polymer cast headers, feedthroughs, usability study translation
Preferred skills
Class III medical device experience, FEA, fatigue testing, biomedical materials, plastic injection molding, welding, manufacturing methods for implantable devices, implantable device design, surgical tool design, lead design, polymer cast headers, feedthroughs, hermetic sealing, usability studies, clinical feedback translation
Technologies
Solid modeling tools, FEA software, GD&T standards, injection molding equipment, welding equipment
Responsibilities
Design mechanical components, assemblies, prototypes, and test fixtures; Establish and maintain mechanical requirements, specifications, and system-level constraints; Conduct solid modeling, tolerance stack analysis, and GD&T-based mechanical design; Interface with external vendors to develop prototypes, assess manufacturability, and optimize fabrication approaches; Develop and execute mechanical experiments, including test method definition, test setup design, and data analysis; Investigate mechanical failure modes and drive design changes through structured problem solving; Support development activities in compliance with FDA regulations and ISO standards for Class III implantable medical devices; Prepare, process, and maintain engineering documentation such as ECOs, reports, and design files; Contribute to verification and validation strategy and execution for mechanical subsystems; Lead cross-functional project team(s) to deliver mechanical solutions aligned with program goals; Influence product architecture, system-level trade-offs, material selection, and manufacturing strategies; Anticipate mechanical risks and proactively guide mitigation plans; Collaborate closely with systems, electrical, firmware, manufacturing, quality, and regulatory teams to ensure seamless system integration; Communicate effectively with physicians and clinicians to gather user insights and integrate feedback into design decisions; Evaluate new materials, manufacturing processes, and design methodologies to support feasibility and concept development; Support laboratory and clinical research activities by developing prototypes, fixtures, and investigational designs; Contribute to early-stage concept development and participate in intellectual property generation; Follow quality system procedures, documentation practices, and laboratory standards; Supports risk management documentation including hazard analysis and failure modes and effect analysis (FMEA) to identify and mitigate design and process risks; Drive continuous improvement in mechanical design processes, test methods, and development workflows; Ensure all mechanical deliverables meet performance, reliability, and compliance requirements.
Seniority
Mid-Senior, hands-on IC with technical leadership