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Owns the lifecycle of manufacturing equipment, fixtures, tooling, and inspection systems. Responsibilities include equipment documentation, preventive maintenance programs, metrology equipment specification and qualification, validation support, Gage R&R studies, sustaining backlog management, and root-cause investigations. The role partners with technicians, Quality, vendors, and Manufacturing Engineering in a regulated manufacturing environment, supporting medical-device equipment and process controls.

Leads manufacturing engineering for medical device commercial production, including new product introduction, process transfer, validation, automation, equipment qualification, tooling, sustaining engineering, and continuous improvement. Supervises engineering staff, manages KPIs and capital projects, supports troubleshooting and CAPA investigations, and ensures compliance with 21 CFR Part 820, ISO 13485, GDP, EHS policies, and customer requirements.

The Senior Quality Assurance Engineer ensures operational quality in manufacturing, supports audits, manages nonconformances, and oversees compliance with quality systems and regulations.

The Senior Software Engineer develops and maintains software/firmware for innovative medical technologies, collaborating with teams, mentoring junior engineers, and ensuring quality through documentation and testing.

Develops and maintains capacity-balanced master production schedules across medical device client programs. Converts forecasts and orders into executable ERP/MRP plans, manages work orders, capacity constraints, materials, inventory, and planning master data. Coordinates with manufacturing, procurement, quality, program management, and clients to protect delivery commitments. Supports S&OP, dashboards, scenario planning, continuous improvement, and compliance with medical device quality and regulatory requirements.

The Principal Electrical Engineer will lead design and testing of electronic systems for medical devices, mentor junior engineers, and engage with clients to ensure product compliance and excellence.

The Quality Systems Manager oversees the Quality Management System, ensuring compliance and managing quality initiatives across Nextern US sites.