Product Development Engineer
Core
Lead design and development of realistic surgical training models to improve user experience, training effectiveness, and manufacturability for medical device customers.
Role type
Senior IC mechanical/biomedical product development engineer
Builds
Physical surgical training models and prototypes for medical device manufacturers
Domain
Medical devices / Surgical training / Mechanical engineering
Deliverable
physical/clinical work
Required skills
Mechanical or biomedical engineering design, CAD modeling (SolidWorks), prototyping (machining, 3D printing, laser cutting), ISO 9001 quality systems, root cause analysis, design failure mode analysis, component fabrication methods, manufacturing process documentation, supplier/vendor management
Preferred skills
MS in engineering, FDA/ISO regulated environment experience, injection molding/hydrogel/silicone molding, design of experiments, lean manufacturing, Six Sigma, packaging design
Technologies
SolidWorks, Fusion, SmartSheet, Microsoft Office, Excel, Visio, Powerpoint
Responsibilities
Lead product development projects for model iterations and design changes, resolve engineering challenges through rapid prototyping and testing, create design documentation including part specifications and BOMs, interface with manufacturing and quality engineering for scalable production, perform root cause investigations and design failure mode analyses, document manufacturing process instructions, support new model introductions to manufacturing lines, sustain existing designs to meet cost targets
Seniority
Senior, hands-on IC