Principal Engineer - Global Process Technologies

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

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

What You Can Expect

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.

How You'll Create Impact

• Lead the development, review, and continuous imrpovement 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.

What Makes You Stand Out

• Demonstrated experience with engineering specifications, process controls, manufacturing documentation, and change management.
• Experience supporting FDA-regulated manufacturing environments.
• Working knowledge of process validation, risk management, nonconformance investigation, and CAPA preferred.
• 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.

Preferred Experience

• 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.

Your Background

• Bacehlor's degree in Engineering or a related technical field required ; advanced degree preferred.
• 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.

Expected Compensation Range

$114,000 - $142,000

EOE