SaMD Systems Designer

Position 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.

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.

Qualification & Experience:

• 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.

Education Requirements

Bachelor's degree in engineering or science related field; biomedical engineering preferred

Location: Remote (MST only) Assignment Duration: 8 months Work Arrangement: Remote