Design Assurance Engineer

Job Description

Medical Device client is seeking a Design Assurance Engineer (R&D Engineer) to support multiple critical projects with upcoming submission deadlines over the next three months. This individual will play a key role in driving project execution and ensuring timely completion of deliverables, with primary project timelines targeted for completion by the end of August. This is a fast-paced role requiring strong multitasking capabilities, adaptability, and the ability to quickly ramp on new tasks.

• Support multiple concurrent projects with aggressive timelines, ensuring milestones and deliverables are completed on schedule
• Execute and support thermal testing and tablet hardware testing (training will be provided if needed)
• Develop, review, and execute test protocols and reports in alignment with medical device standards
• Support design assurance activities for an implantable medical device system (epilepsy-focused technologies)
• Contribute to documentation aligned with medical device regulatory requirements
• Review and support activities related to system-level components, including batching and tablet-based system integration
• Collaborate cross-functionally with:
  • R&D Engineers
  • Manufacturing Engineers
  • Project Managers
• Effectively manage and prioritize multiple tasks simultaneously while maintaining quality and compliance standards

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

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• 4–5+ years of experience in medical device engineering (R&D, Quality, or Design Assurance)
• Direct experience writing design verification protocols and/or reports
• Strong understanding of:
  • Design verification / validation (DV/V)
  • Design controls and documentation structure
  • Experience working in a regulated environment (FDA or ISO)
• Bachelor’s degree in Engineering (Electrical, Biomedical, Mechanical, or related)
• Ability to work in a fast-paced environment and quickly ramp on new projects
• Familiarity with:
  • ISO 13485
  • FDA 21 CFR Part 820 / Part 11
  • Risk management (ISO 14971)
  • Experience with implantable medical devices or neuromodulation products
• Exposure to system-level testing (hardware + software integration)
• Background in:
  Thermal testing or Electromechanical or tablet/interface-based systems