System Designer

Position: Systems Designer (SaMD)

Location: Warsaw IN
Duration: 8-Month Contract

We are seeking an experienced Systems Designer with a strong background in medical device design controls and product development. The ideal candidate will play a key role in refining documentation ensuring regulatory compliance and supporting the development of Software as a Medical Device (SaMD) products. This role requires close collaboration with cross-functional teams to maintain alignment with regulatory and quality standards.

• Define and drive system design approaches aligned with product objectives user needs and clinical workflows
• Translate system requirements into practical and scalable design solutions
• Lead technical design discussions reviews and evaluate trade-offs
• Ensure designs address usability risk mitigation technical feasibility and long-term sustainability

• Develop and execute verification and validation (V&V) protocols test methods and performance specifications
• Perform manual and automated testing and accurately document results

• Author review and maintain Design History File (DHF) documentation including user needs design inputs/outputs traceability matrices and risk documentation
• Ensure all product requirements are traceable to verification and validation activities
• Maintain compliance with FDA regulations ISO standards and internal design controls
• Collaborate with QA Regulatory Service and Compliance teams to meet documentation requirements
• Support risk management activities including uFMEA and cybersecurity risk documentation
• Proactively identify and address gaps in documentation and compliance

• Bachelors degree in Engineering or a related field (Biomedical Engineering preferred)
• 5 years of experience in medical device or regulated product development environments
• Strong experience with Software as a Medical Device (SaMD)
• Proven expertise in design controls within a cross-functional organization
• Hands-on experience with DHF documentation traceability and risk management
• Familiarity with ISO 14971 (IEC 62366 preferred)
• Ability to define testable requirements and support V&V activities
• Strong analytical problem-solving and decision-making skills
• Excellent written and verbal communication skills

• Experience with tools such as Codebeamer Jira or similar ALM systems
• Ability to work effectively with internal and external stakeholders in a regulated environment

• Strong collaboration across R&D QA Clinical and Regulatory teams
• Attention to detail and commitment to quality and compliance
• Ability to manage multiple priorities in a fast-paced environment