Product Quality Sr Designer I

The Product Quality Sr Designer at Zimmer Biomet is responsible for refining product documentation, ensuring regulatory compliance, and supporting the design and testing of medical technology products. The role involves leading agile practices, managing project planning and execution, and collaborating with cross-functional teams. Key responsibilities include defining system design, translating user needs into engineering requirements, leading technical reviews, and managing product verification and validation. Candidates should have a bachelor’s degree in engineering or a science-related field, at least 5 years of relevant experience, and expertise in medical device design controls, regulatory compliance, and documentation. Familiarity with ISO 14971, IEC 62366, and tools such as Windchill, Codebeamer, or Jira is required. Strong analytical, communication, and collaboration skills are essential.

The Product Quality Sr Designer at Zimmer Biomet plays a pivotal role in refining existing documentation and ensuring regulatory alignment to support both new and existing products. This position is responsible for leading agile practices, supporting project planning, and maintaining project tracking boards. The role involves defining design approaches, translating user needs into engineering requirements, and ensuring compliance with international standards. Collaboration with cross-functional teams is essential to meet documentation requirements and maintain regulatory compliance. The position offers opportunities for professional development within a supportive and inclusive environment, with a focus on innovation and continuous improvement in medical technology.

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

• Project Management
• Lead and promote agile practices across scrum teams.
• Support project planning and execution.
• Maintain roadmaps, backlogs and project tracking boards.
• System Design
• 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.
• System Testing
• Implement and review product verification and validation (V&V) testing, including developing test protocols and test cases.
• Perform manual and automated testing and document results accurately.
• Product Documentation
• Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment.
• Create, review, and maintain risk management files, including cybersecurity risks.
• Ensure all product requirements are documented and maintained.
• Ensure compliance with international standards and regulations.
• Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.

What Makes You Stand Out

• Experienced with agile methodology, preferably holds a previous role as a scrum master.
• Strong analytical skills and accurate judgment-making skills.
• Ability to deal effectively with internal and external collaborators.
• Excellent communications skills; written and verbal.

Your Background

• Bachelor’s degree in engineering or science related field; biomedical engineering preferred.
• 5+ years of experience.

Ideally you have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation. This comes with the following:

• Experience with Software as a Medical Device (SaMD).
• 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 Windchill, Codebeamer, Jira, or similar.

EOE/M/F/Vet/Disability

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

Responsibilities:

• Lead and promote agile practices across scrum teams.
• Support project planning and execution to ensure timely delivery of product requirements.
• Maintain roadmaps, backlogs, and project tracking boards to track progress and deliverables.
• 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.
• Implement and review product verification and validation (V&V) testing, including developing test protocols and test cases.
• Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment.
• Create, review, and maintain risk management files, including cybersecurity risks, and ensure compliance with international standards and regulations.
• Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.

Skills:

• Experience with agile methodology, preferably holding a previous role as a scrum master.
• Strong analytical and accurate judgment-making skills are essential.
• Excellent written and verbal communication skills are required.
• Experience with Software as a Medical Device (SaMD) is necessary.
• Solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation.
• Experience drafting and maintaining DHF content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation.
• Ability to support risk analysis such as uFMEA and contribute to usability planning and design mitigations.
• Familiarity with ISO 14971 is required, and IEC 62366 is preferred.
• Experience with tools such as Windchill, Codebeamer, Jira, or similar platforms is necessary.
• Experience in a regulatory environment with strict compliance is required.

Education:

• A bachelor’s degree in engineering or a science-related field is required; biomedical engineering is preferred.