The Manufacturing Engineering Manager leads the manufacturing engineering team supporting new product introduction and transfer, process development and validation, automation, and sustaining engineering at Nextern’s US medical device CDMO site, delivering capable, compliant, and cost-effective manufacturing processes in support of commercial production at the Maple Grove facility. Working knowledge of 21 CFR Part 820, ISO 13485, and Good Documentation Practices; experience with design controls, risk management (ISO 14971), pFMEA, and CAPA.