System Designer

Job Title: Systems Designer Duration: 8 Months with possible extension Location: REMOTE Summary: The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation. You’ll play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products. Candidates must have experience with software as a medical device (SaMD). Requirements • 5+ years of 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. • Able 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. • Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders. • Must have experience in a regulatory environment with strict compliance. • Strong analytical skills and accurate judgment-making skills. • Ability to deal effectively with internal and external collaborators. • Excellent communications skills; written and verbal. • Experience with Codebeamer, Jira, or similar. Duties and Responsibilities: System Design • Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance. • Translate user needs and system requirements into practical design solutions. • 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 protocols, test methods, and performance specifications. • 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 kept up-to-date. • 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. Education Requirements: • Bachelor’s degree in engineering or science related field; biomedical engineering preferred.