Staff R&D Engineer- NPD (Onsite Irvine, CA)
Core
Lead the design, development, and optimization of mechanical medical device components, assemblies, and subsystems from concept through commercialization.
Role type
Staff R&D Mechanical Engineer (Medical Devices)
Builds
Mechanical and electro-mechanical medical device products
Domain
Medical Devices / Mechanical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mechanical product design, Design for Manufacturability (DFM), materials selection, manufacturing processes, mechanical problem-solving, GD&T, 3D CAD modeling, prototyping, verification and validation testing, data analysis, root-cause investigation, Design Controls, Risk Management, Quality Management Systems
Preferred skills
machine shop operations, injection molding, additive manufacturing (3D printing), FDA submission support (510(k), PMA), MS Project, Minitab
Technologies
SolidWorks, Microsoft Office Suite
Responsibilities
Translate user and clinical needs into engineering specifications and system-level product requirements; develop and execute design verification and validation strategies including prototyping and testing; create and maintain engineering documentation including CAD models, drawings, and Design History File (DHF) deliverables; collaborate cross-functionally with Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams; ensure compliance with medical device regulations, industry standards, and quality system requirements.
Seniority
Staff, hands-on IC