Senior Project Engineer
Core
Executes innovation and development of project elements focusing on manufacturing processes, technology, and procedures for new product manufacture.
Role type
Senior Project Engineer (Manufacturing/Process Development)
Builds
New products and manufacturing processes for medical devices
Domain
Medical Devices / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical engineering fundamentals, process design, component selection, equipment validation, PFMEA, Control Plan, SOP, PPAP generation, capability studies, MSA studies, GMP compliance, safety procedures, engineering drawing interpretation, GD&T
Preferred skills
FDA regulated industry experience, capital acquisition negotiation, experimental test analysis, training manufacturing teams
Technologies
None explicitly stated
Responsibilities
Provide engineering support for new product and process introductions, ensure quality of process and product, assist in component and equipment selection, support capital acquisition activity, analyze equipment and conduct experimental tests, participate in process review meetings, generate validation documentation, conduct MSA and capability studies, provide training to manufacturing team
Seniority
Mid-level, hands-on IC
