Product Quality Sr Designer I

Quick Facts

Product Quality Sr Designer

What You Can Expect

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

• 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 software specifications, 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, traceable to verifiable tests, 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.

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.

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

Benefits

Expected compensation for this role is $80,000 - 100,000 base salary plus performance bonus.

EOE/M/F/Vet/Disability