Lead Mechanical Engineer
Core
Implement mechanical design changes, product improvements, and documentation updates for an installed base of ultrasound transducers in a regulated medical device environment.
Role type
Lead Mechanical Engineer (Medical Devices)
Builds
Ultrasound transducers (probes) for clinical applications including surgery, urology, cardiology, and radiology
Domain
Medical Devices / Diagnostic Imaging
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design, 3D CAD modeling (SolidWorks/Creo), GD&T, tolerance analysis, mechanical materials, measurement tools (CMM/calipers/micrometers), Design for Manufacturability (DFM), Design for Assembly (DFA), PLM/PDM systems, Design verification and validation (V&V), risk management (DFMEA)
Preferred skills
Legacy product support, injection molding, additive manufacturing, FDA/ISO 13485 compliance knowledge
Technologies
SolidWorks, Creo, Agile, SolidWorks PDM, MyWorkshop
Responsibilities
Support mechanical design updates across an existing portfolio, translate manufacturing/quality inputs into design solutions, design and document new components and modifications, develop solutions for transducer housings and subsystems, create and manage engineering changes (ECOs) and drawings, maintain configuration control in PLM/PDM systems, apply DFM/DFA principles, support V&V activities, participate in risk management processes, ensure compliance with FDA/ISO standards
Seniority
Mid-level, hands-on IC