Product Quality Sr Designer I

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

As a Product Quality Sr Designer, you will play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products.

How You'll Create Impact

System Design
o    Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance. 
o    Translate user needs into engineering level requirements that are objectively verifiable. 
o    Lead design discussions and technical reviews, evaluating alternatives and trade-offs. 
o    Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability.

System Testing
o    Implement and review product verification and validation (V&V) testing, including developing software specifications, test protocols and test cases. 
o    Perform manual and automated testing and document results accurately. 

Product Documentation
o    Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment. 
o    Create, review, and maintain risk management files, including cybersecurity risks. 
o    Ensure all product requirements are documented, traceable to verifiable tests, and maintained. 
o    Ensure compliance with FDA, ISO, and internal design controls. 
o    Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.

What Makes You Stand Out

•    Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.
•    Strong analytical skills and accurate judgment-making skills.
•    Ability to deal effectively with internal and external collaborators.
•    Excellent communications skills; written and verbal.

The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation.

Your Background

•    Bachelor's Degree and 4 years of relevant experience or equivalent experience
•    Strong experience with Software as a Medical Device (SaMD).
•    Strong experience in design controls in a multi-disciplinary organization.
•    Experience drafting and maintaining DHF (design history file) content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation.
•    Ability to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations.
•    Familiarity with ISO 14971 is required, and IEC 62366 preferred.
•    Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
•    Experience in a regulatory environment with strict compliance.
•    Experience with Codebeamer, Jira, or similar.

Expected compensation for this role is $80,000 - 100,000 base salary plus performance bonus.

EOE/M/F/Vet/Disability