Design Assurance Engineer

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.

Key Responsibilities
• 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:
o R&D Engineers
o Manufacturing Engineers
o Project Managers
• Effectively manage and prioritize multiple tasks simultaneously while maintaining quality and compliance standards

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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

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.