Product Quality Sr Designer

About the role

Zimmer Biomet is seeking a Product Quality Sr Designer to join our team. This position plays a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products.

Responsibilities

• Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance.
• Translate user needs into engineering level requirements that are objectively verifiable.
• Lead design discussions and technical reviews, evaluating alternatives and trade-offs.
• Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability.
• Implement and review product verification and validation (V&V) sing, including developing software specifications, protocols, and cases.
• Perform manual and automated testing and document results accurately.
• Create, review, and maintain risk management files, including cybersecurity risks.
• Ensure all product requirements are documented, traceable to verifiable standards, and maintained.
• Ensure compliance with FDA, ISO, and internal design controls.
• Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.

Requirements

• Bachelor's Degree and 4 years of relevant experience or equivalent experience is required.
• The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation.
• 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 software 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.

Qualifications

• 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.
• Able to deal effectively with internal and external collaborators.
• Excellent communications skills; written and verbal.

Skills

• Software as a Medical Device (SaMD) experience.
• Design controls in a multi-disciplinary organization.
• Experience drafting and maintaining DHF (design history file) content.
• Ability to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations.
• Familiarity with ISO 14971 and IEC 62366.
• Ability to define software 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.

Benefits

Expected Compensation - $80,000 - 100,000 base salary. EOE/M/F/Vet/Disability