The Manufacturing Engineer will own the manufacturing documentation, processes, equipment, and production-readiness activities supporting the company’s existing and new medical devices. This role will develop and qualify manual manufacturing processes; maintain build documentation; ensure tools, equipment, facilities, calibration, preventive maintenance, cleanroom monitoring, and EO processing documentation remain current; and coordinate material and process-aid availability for planned production. The ideal candidate is a hands-on medical device Manufacturing Engineer who can establish practical processes, organize cross-functional projects, improve yield and reliability, and support products from development through transfer and routine manufacturing.
Must-Have Qualifications
Candidates must meet the following Must-Have qualifications. These are the core requirements for the role:
• 5+ years of hands-on Manufacturing Engineering experience in an ISO 13485 medical device manufacturing environment.
• Demonstrated ownership of manufacturing processes and documentation, including DMR content, BOMs, routers, work instructions, build travelers or packets, manufacturing records, and change control.
• Demonstrated experience developing, documenting, and qualifying manual assembly or manufacturing processes, including validation strategy, protocols, reports, acceptance criteria, and objective evidence.
• Experience selecting and implementing tools, fixtures, gages, process aids, and manufacturing equipment, including equipment qualification, calibration controls, and preventive maintenance systems.
• Strong production-support and process-improvement background, including troubleshooting, root cause analysis, defect reduction, yield improvement, process capability, and corrective action implementation.
• Experience coordinating production readiness and material availability, identifying shortages and constraints, and working with purchasing resources, suppliers, production personnel, and cross-functional stakeholders.
• Experience supporting controlled-environment or cleanroom manufacturing, including coordination of monitoring, facility controls, maintenance activities, and associated documentation.
• Demonstrated experience defining and managing manufacturing or operations-related projects, including coordinating cross-functional resources, tracking deliverables, maintaining timelines, escalating risks, and driving actions to completion.
• Excellent technical writing, organization, follow-through, practical judgment, and cross-functional communication skills.
Education and Certifications
• Bachelor’s degree in Manufacturing, Mechanical, Biomedical, Industrial, or a related Engineering discipline required; equivalent direct medical device manufacturing experience may be considered.
• Certified Manufacturing Engineer, Six Sigma, ASQ CQE, PMP, or related technical or project-management certification preferred.
How to apply.
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