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.
Travel Expectations
