Product Quality Sr Designer I

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.

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.

• 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.

• 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.

EOE/M/F/Vet/Disability