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.
