Quality Sr Engineer I
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Zimmer, Inc.
Salt Lake City, UT, US
Summary
The Senior Quality Engineer supports the design, development, and lifecycle of medical device software, including AI integration. Key duties include leading risk management, verification and validation activities, and ensuring compliance with regulatory and industry standards.
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 talent 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 included, respected, empowered and recognised.
What You Can Expect
The Senior Quality Engineer supports the design, development, and lifecycle support of medical device hardware for new and existing products, including electrical devices and hardware supporting medical device software. This role works closely with design and cross-functional teams to support new product introductions, maintain hardware design and development documentation, and ensure compliance with applicable quality, regulatory, and industry standards. The position plays a key role in risk management, hardware verification and validation activities, design reviews, equipment qualification, and implementation of hardware changes throughout the product lifecycle.
How You'll Create Impact
- Partner with design and cross-functional development teams to support quality activities for new product introductions as well as maintenance on existing product lines.
- Lead or contribute to design, implementation, integration, and maintenance for product development projects.
- Maintain product design documentation and ensure it remains current throughout the product lifecycle.
- Support product changes, enhancements, defect corrections, and sustaining engineering activities for released products.
- Lead risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
- Support verification and validation planning, protocol development, execution, and documentation.
- Participate in design reviews and provide technical guidance to ensure robust, compliant, and maintainable solutions.
- Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
- Review and approve technical documentation, including, design documents, test protocols, traceability matrices, and change records.
- Provide technical leadership for complex troubleshooting, root cause investigations, and continuous improvement initiatives.
- Mentor engineers and serve as a technical leader across multiple projects and product platforms.
- Support audit, inspection, and regulatory submission readiness activities as needed.
What Makes You Stand Out
- Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, resource management, product realization and measurement, analysis and improvement processes.
- Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control
- Experience with creating Quality infrastructure and guidelines for Medical Device Hardware
- Demonstrated technical expertise
- Demonstrates ownership for the integrity of work
- Able to work independently or as part of a team and consider options for completing work
- Strong written and verbal communication skills
Your Background
- Bachelor’s Degree in Quality or Engineering field, or an equivalent combination of education and experience.
- Must be familiar with Microsoft Office Suite
- Must have minimum of 5 years of experience in Quality Engineering field
- Experience of working in a regulated industry, preferably medical devices.
- Experience working within a quality management system compliant with ISO 13485.
- Strong written and verbal communication skills.
- Proven ability to work effectively across cross-functional teams and influence technical decisions.
Physical Requirements
Travel Expectations
Up to 15%
Salary Expectations:
$80,000 - $101,000
On site in Salt Lake City, Utah
EOE/M/F/Vet/Disability
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We advance our mission to alleviate pain and improve the quality of life for patients around the world with our innovative products and suite of integrated digital and robotic technologies leverage data, data analytics and artificial intelligence. Founded in 1927 and based in Warsaw, Zimmer Biomet has operations in more than 25 countries and sales in more than 100 countries. We maintain world-class scientific facilities and resources and collaborate with leading clinicians and researchers around the world.
Awards and Recognitions
• Forbes: America's Best Companies 2026
• Workhuman: Luminary Award 2025 & Innovator Award 2024
• TIME: America's Best Companies [Mid-Size] 2024
• Great Place to Work - Best Workplaces: Switzerland & Poland 2025
• Great Place to Work Certified 2025 - 2026: USA, Poland, India, Colombia, Ireland, Puerto Rico, Kingdom of Saudi Arabia, Switzerland
• MedTech: Breakthrough Award Best New Technology Solution in Orthopedics 2025
• Top Employers Institute: China 2025
• VETS Indexes: 4 Star Employer 2025
Company size
10,001+ employees
Industry
Medical Equipment Manufacturing
Org type
Public Company
Headquarters
Warsaw, Indiana
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. We advance our mission to alleviate pain and improve the quality of life for patients around the world with our innovative products and suite of integrated digital and robotic technologies leverage data, data analytics and artificial intelligence. Founded in 1927 and based in Warsaw, Zimmer Biomet has operations in more than 25 countries and sales in more than 100 countries. We maintain world-class scientific facilities and resources and collaborate with leading clinicians and researchers around the world.
Awards and Recognitions
• Forbes: America's Best Companies 2026
• Workhuman: Luminary Award 2025 & Innovator Award 2024
• TIME: America's Best Companies [Mid-Size] 2024
• Great Place to Work - Best Workplaces: Switzerland & Poland 2025
• Great Place to Work Certified 2025 - 2026: USA, Poland, India, Colombia, Ireland, Puerto Rico, Kingdom of Saudi Arabia, Switzerland
• MedTech: Breakthrough Award Best New Technology Solution in Orthopedics 2025
• Top Employers Institute: China 2025
• VETS Indexes: 4 Star Employer 2025
Company size
10,001+ employees
Industry
Medical Equipment Manufacturing
Org type
Public Company
Headquarters
Warsaw, Indiana