Senior Global Process Controls Engineer - Medical Devices

Zimmer Biomet; Warsaw (IN); On-site; USD 114,000 - 142,000; Full time

Job summary

Zimmer Biomet in Indiana seeks a seasoned engineering leader to strengthen specifications and process controls for medical device manufacturing. You will partner across Operations, Quality, Regulatory Affairs, R&D, and Supplier Quality to translate product requirements into robust manufacturing methods.

You will shape how products are built, controlled, and improved across their lifecycle, mentoring teams and leading audits and CAPA in FDA-regulated environments.

Qualifications

• Bachelor's degree in Engineering is required; advanced degree preferred.
• Typically 10+ years of engineering experience in a medical device or highly regulated environment.
• Strong background in operations, manufacturing, process, or quality engineering.

Responsibilities

• Lead development and review of engineering specifications for devices, components, materials, assemblies, labeling, and packaging.
• Define and strengthen production and process controls to ensure consistent manufacturing performance and regulatory compliance.
• Assess changes for impact on operations, validation, and documentation.
• Support design transfer by translating outputs into manufacturing specs and acceptance criteria.
• Collaborate with cross-functional teams to investigate nonconformances and drive data‑driven improvements.
• Contribute to process validation, risk management, and control plans.

Skills

engineering leadership

process controls

data-driven problem solving

cross-functional collaboration

regulatory compliance

Education

Bachelor's degree in Engineering

Advanced degree

Job description

Zimmer Biomet in Indiana seeks a seasoned engineering leader to strengthen specifications and process controls for medical device manufacturing. You will partner across Operations, Quality, Regulatory Affairs, R&D, and Supplier Quality to translate product requirements into robust manufacturing methods.

You will shape how products are built, controlled, and improved across their lifecycle, mentoring teams and leading audits and CAPA in FDA-regulated environments.