MicroTransponder · 5 hours ago
Principal Design Assurance Engineer
Minneapolis, MN
Full-time
Onsite
Senior Level, Lead/Staff
$110K/yr - $160K/yr
10+ years expMicroTransponder, Inc. is dedicated to transforming the lives of stroke survivors through its innovative neurostimulation technology. The Principal Design Assurance Engineer supports product design and development activities, ensuring compliance with regulatory requirements and company standards while applying electrical engineering expertise to medical device design and verification.
Medical DeviceHealthcareLife ScienceHealth CareMedicalNeuroscience
Responsibilities
Provide Design Assurance leadership throughout the design and development of new hardware and electrical medical device products
Support post-market sustaining activities including failure analysis, design change development and implementation, supplier performance evaluation, certifications, complaint investigations, and nonconformance disposition
Lead root cause investigations, corrective action development, and verification of effectiveness
Lead and support compliant development, verification, validation, and transfer of new products and processes into manufacturing
Serve as a subject matter expert in hardware and electrical design controls, risk management, verification & validation, and DHF maintenance
Support new process development, test method development and validation, process characterization, and technical investigations
Lead and participate in design verification and validation activities with clear documentation
Ensure hardware and electrical designs meet regulatory and company standards for quality, safety, performance, and reliability
Apply sound engineering methodologies to resolve technical issues and drive improvements
Collaborate with Product Development, Sustaining Engineering, Quality, Regulatory, and Operations teams
Participate in design reviews and phase-gate reviews
Contribute to project planning, cost estimates, schedules, and performance requirements
Prepare and deliver technical presentations
Provide leadership and mentoring to engineers and project team members
Support audits and regulatory inspections
Provide backup support for other QA functions
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Electrical, Biomedical, Mechanical Engineering, or related discipline with 10+ years of progressive experience, or equivalent combination of education and experience
Experience applying hardware and electrical design controls in regulated industries
Strong knowledge of: Medical device design controls, Risk management, New product development, DHF maintenance, Verification and validation testing
Experience with test method development and validation
Strong communication skills with ability to explain technical concepts clearly
Demonstrated ability to lead technical teams through collaboration and influence
In-depth knowledge of applicable regulations and standards, including: FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 61010 (as applicable), ISO 10993 (as applicable), EU MDR
Strong analytical and problem-solving skills
Ability to work independently while exercising sound judgment
Proficiency with Microsoft Office and engineering/documentation tools
Strong organizational and time-management skills
Demonstrated success achieving quality and compliance objectives
Preferred
Quality engineering experience or certification preferred
Benefits
Medical, dental and vision plans
FSA
401(k) plan with company matching
Unlimited Paid Time Off (PTO) program
Approximately 18 paid company holidays per year
Company
MicroTransponder
MicroTransponder is a medical device company that develops and commercializes neurostimulation devices to treat neurological diseases.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$180.12MKey Investors
U.S. Venture PartnersMedTech InnovatorGreen Park & Golf Ventures
2025-03-12Series F· $65M
2023-06-06Non Equity Assistance
2022-06-20Series E· $73M
Leadership Team
Richard Foust
Chief Executive Officer
Bunker Curnes
Chief Financial Officer
Recent News
2025-08-05
Company data provided by crunchbase