Cnc machining programming and shop floor inspection
Process validation iq oq pq expertise
Acumed LLC is seeking a Senior Manufacturing Engineer to oversee the lifecycle of their medical devices, focusing on production processes that adhere to regulatory standards. The ideal candidate will have extensive experience in manufacturing engineering within a regulated environment, particularly in medical device manufacturing
Job Summary
The Senior Manufacturing Engineer owns the continuous improvement of existing processes through waste elimination and adoption of new manufacturing methods.
This role ensures all manufacturing processes align with Good Manufacturing Practices (GMPs) to support a quality-first culture in a highly regulated environment.
Candidates will lead initiatives to adopt new manufacturing technologies tailored to patient-matched production while maintaining a strong presence on the shop floor.
Matching Summary
Match Score: 85
Acumed LLC is seeking a Senior Manufacturing Engineer to oversee the lifecycle of their medical devices, focusing on production processes that adhere to regulatory standards. The ideal candidate will have extensive experience in manufacturing engineering within a regulated environment, particularly in medical device manufacturing.
Skills & Requirements
Must-have
5+ years manufacturing engineering experience
CNC machining programming and shop floor inspection
Process validation IQ OQ PQ expertise
FDA and ISO 13485 regulatory knowledge
Advanced proficiency in 3D CAD software
Statistical tools Minitab JMP capability analysis
FMEA risk management application
Nice-to-have
Patient-specific or customized manufacturing workflows
3D printing SLA background preferred
Mentorship of junior engineers and technicians
Go and see mentality on shop floor
Experience with parts washing and anodization
Leadership in cross-functional teams
Key Requirements
Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial)
5+ years of experience in manufacturing engineering
Knowledge of FDA regulations and ISO 13485 standards