Principal Engineer - Global Process Technologies

Zimmer, Inc.•Warsaw, IN

10d•$114,000 - $142,000

About The Position

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. You will help shape how products are built, controlled, and continuously improved across their lifecycle.

Requirements

Demonstrated experience with engineering specifications, process controls, manufacturing documentation, and change management.
Experience supporting FDA-regulated manufacturing environments.
Ability to lead complex technical initiatives and influence cross-functional stakeholders in a global or multi-site environment.
Strong analytical, communication, and technical problem-solving skills.
Bachelor's degree in Engineering or a related technical field required.
Typically 10+ years of engineering experience in the medical device industry or another highly regulated manufacturing environment.
Strong background in operations, manufacturing, process, or quality engineering.

Nice To Haves

Working knowledge of process validation, risk management, nonconformance investigation, and CAPA preferred.
Experience in orthopedic, dental, robotic, implantable, or other medical device product lines.
Familiarity with machining, molding, assembly, cleaning, sterilization, packaging, or supplier-controlled processes.
Experience with statistical methods, process capability analysis, and manufacturing data trending.
Experience supporting regulatory inspections or quality system remediation initiatives.
Advanced degree preferred.

Responsibilities

Lead the development, review, and continuous improvement of engineering specifications for devices, components, materials, assemblies, labeling, and packaging, as applicable.
Define and strengthen production and process controls that support consistent manufacturing performance, product quality, and regulatory compliance.
Assess design, process, material, equipment, and supplier changes for operational, validation, and documentation impact.
Support design transfer activities by ensuring design outputs are effectively translated into manufacturing specifications, methods, and acceptance criteria.
Partner with cross-functional teams to investigate nonconformances, deviations, and other quality issues using structured, data-driven problem solving.
Contribute to process validation strategies, risk management activities, and control plans appropriate to product and process risk.
Provide technical leadership during audits, inspections, and remediation efforts related to manufacturing controls and specification management.
Mentor engineers and technical teams in specification development, compliant documentation, and risk-based decision making.