Responsible for driving the transition of complex, multidisciplinary medical devices from design to sustainable serial production through the ECO process, as well as sustaining and optimizing active manufacturing lines.
The scope encompasses process design, yield optimization, system -level troubleshooting (mechanics, electronics), and strict adherence to medical device quality regulations (ISO 13485 / FDA 21 CFR Part 820).
Requirements: BOM maintenance PLM:
High proficiency in drafting technical documents, Standard Operating Procedures (SOPs), and navigating Product Lifecycle Management (PLM) systems for bill of materials (BOM) management.
Multidisciplinary Troubleshooting:
Strong systems-level diagnostic skills to root-cause failures occurring at the intersection of mechanical, electrical, or firmware subsystems.
Validation Risk Management:
Practical proficiency in writing and executing validation protocols (IQ/OQ/PQ, TMV) and conducting risk analysis (pFMEA)
Subordinate to:Engineering Director
This position is open to all candidates.