With general direction, represents Product Compliance (PC) working cross-functionally to ensure engineering design control outputs meet customer and regulatory requirements.
Work with Regulatory Affairs (RA) and Quality Assurance (QA) to establish regulatory and quality requirements.
Work with Business Unit (BU) Marketing, Sales, and Program Management to define customer requirements.
Work with Engineering and Manufacturing to translate requirements into design control activities and deliverables.
Work cross-functionally to implement the required design control activities and deliverables.
With QA oversight, ensure Verification and Validation (V&V) results demonstrate requirements are met.
Provide design control guidance and training to less experienced personnel.
Support RA and QA product, process, and supplier problem investigations and remediation.
Performs other duties as assigned.
BSEE or equivalent and five or more years of related experience, including minimum of two years PA, QA, SQA, QE, or QC experience in Medical Electrical device industry. Working knowledge of 21 CFR Part 820, ISO 13485/14971, IEC 60601, FIT predictions or MIL HDBK 217 methods desirable.