Product Quality Senior Designer

About the Role

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.

Responsibilities

• 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.

Requirements

• Bachelor’s degree in engineering or science-related field; biomedical engineering preferred.
• 5+ years of experience.
• Experience 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 communication skills, both written and verbal.

Qualifications

• Solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation.
• 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) and contribute to usability planning and design mitigations.
• Familiarity with ISO 14971 is required; 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 tools.

Benefits

• Development opportunities and robust employee resource groups (ERGs).
• Flexible working environment.
• Location-specific competitive total rewards.
• Wellness incentives.
• Culture of recognition and performance awards.
• Inclusive, respectful, and empowering work environment.