Global Process Engineering Leader — Medical Devices

Zimmer Biomet; Warszawa; Vor Ort; PLN 443.000 - 552.000; Vollzeit

Zusammenfassung

Zimmer Biomet is seeking a seasoned engineering leader to strengthen the specifications and process controls that support our medical device manufacturing operations.

In this role, you will partner across Operations, Quality, Regulatory Affairs, R&D, and Supplier Quality to translate product requirements into robust, compliant, and scalable manufacturing methods, shaping how products are built and improved across their lifecycle.

Qualifikationen

• Experience with engineering specifications, process controls, manufacturing documentation, and change management.
• Experience supporting FDA-regulated manufacturing environments.
• Strong background in operations, manufacturing, process, or quality engineering.

Aufgaben

• Lead development, review, and improvement of engineering specifications for devices, components, materials, assemblies, labeling, and packaging.
• Define and strengthen production and process controls for consistent manufacturing performance and regulatory compliance.
• Assess design, process, material, equipment, and supplier changes for impact on operations and validation.
• Support design transfer by translating design outputs into manufacturing specs, methods and acceptance criteria.
• Collaborate with cross-functional teams to investigate nonconformances, deviations, and quality issues using data-driven problem solving.
• Contribute to process validation strategies, risk management, and control plans relevant to product risk.

Kenntnisse

Engineering specifications

Process controls

Manufacturing documentation

Change management

FDA-regulated environments

Ausbildung

Bachelor's degree in Engineering or related technical field

Advanced degree preferred

Jobbeschreibung

Zimmer Biomet is seeking a seasoned engineering leader to strengthen the specifications and process controls that support our medical device manufacturing operations.

In this role, you will partner across Operations, Quality, Regulatory Affairs, R&D, and Supplier Quality to translate product requirements into robust, compliant, and scalable manufacturing methods, shaping how products are built and improved across their lifecycle.