System Designer

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. Key Responsibilities System Design

• 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

System Testing

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

Product Documentation & Compliance

• 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

• Bachelor's 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

Preferred 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

Key Competencies

• 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

Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client … + 1 day ago, © 2026 Careerjet All rights reserved