Process Engineer III - Medical Device, Mid-Senior Level Opening
The Process Engineer (PE) supports production cells and new product development teams to meet operational objectives by developing, integrating, and improving production processes and systems. The Process Engineer also ensures compliance to Acumed, FDA, and ISO regulations.
• Develop manufacturing process instructions and documentation
• Develop and implement advanced production fixtures
• Develop new production Routes, Bill of Materials (BOMs), and Inspection Plans via ECOs
• Manage Quality Notification (QN) system and disposition all non-conforming product
• Develop and implement advanced inspection methods and gaging
• Manage and approve corrective/preventative actions (CAR/SCAR)
• Evaluate inspection frequency considering risk management and process capability
• Implement Statistical Process Control (SPC) methods and tools - use to determine root cause of failures and make recommendations in process changes.
• Lead system level Process Improvement (PI) initiatives & implement Lean tools
• Manage all manufacturing details of new product launches
• Review and Approve Process Validation protocols and reports
• Prepare new equipment proposals including ROI justification
• Lead cross-functional groups
• Communicate effectively with management
• Manage multiple projects with limited supervision
• B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent
• 5+ years process engineering or related experience
• Advanced 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
• Applied understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Applied experience with of Process Validation (IQ, OQ, & PQ) requirements
• Applied experience with statistical tools such as control charts, trending, and capability
Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.
As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at [email protected].
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Regulatory Specialist 2
Janki prepares, reviews, and submits technical documentation to various health authorities—ensuring that Acumed receives the necessary registration for its products in all of the countries where it operates.
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