Staff Manufacturing Engineer
Core
Lead complex manufacturing process design, improvement, and qualification for peripheral vascular medical devices, ensuring safety, efficacy, and regulatory compliance.
Role type
Staff Manufacturing Engineer (Technical Lead)
Builds
Medical device components and finished products for peripheral vascular applications
Domain
Medical Devices / Peripheral Vascular / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process design, Qualification/Verification/Validation (QVV), Troubleshooting, New product development, Six Sigma, Materials testing, Cleanroom operations, Supplier evaluation, Risk analysis (FMEA), Cross-functional team leadership
Preferred skills
Statistical software (Minitab)
Technologies
Engineering software, Statistical software
Responsibilities
Lead complex manufacturing process design and improvement activities; Independently lead qualification, verification, and validation (QVV) of manufacturing processes; Troubleshoot and resolve issues related to product safety, quality, cost, and delivery; Drive engineering initiatives and new product development; Design and develop manufacturing equipment in compliance with safety regulations; Participate in design control efforts including risk analysis and validation protocols; Lead supplier sourcing and evaluation efforts; Direct controlled environment operations including cleanroom design and maintenance; Mentor and train cross-functional teams; Lead and coordinate cross-functional project teams to optimize processes and reduce costs
Seniority
Staff, Technical Lead & Mentorship