Principal Design Assurance Engineer (Medical Devices)

TL;DR

Principal Design Assurance Engineer (Medical Devices): Leading design assurance activities for energy-based therapeutic medical devices with an accent on design controls, risk management, and regulatory compliance. Focus on driving design verification strategies, ensuring robust product development, and collaborating across cross-functional teams to deliver life-saving healthcare solutions.

Location: Must be based in Mounds View, Minnesota, USA (Onsite 4 days per week).

Salary: $132,000–$198,000 USD.

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Lead design assurance activities throughout the full product development lifecycle.
• Own design verification strategies, ensuring alignment between design inputs and test plans.
• Partner with R&D as the subject matter expert for design validation and human factors strategies.
• Ensure traceability between design requirements, risk management, and verification test methods.
• Contribute to risk management activities including DFMEA/FMECA and hazard analysis per ISO 14971.
• Collaborate with cross-functional teams including Systems, Software, Hardware, and Regulatory Affairs.

Requirements

• Bachelor’s degree in a technical field with 7+ years of experience OR Advanced degree with 5+ years of experience.
• Strong understanding of design control principles.
• Must be able to work onsite in Mounds View, MN, at least 4 days per week.
• Must possess unrestricted U.S. work authorization (sponsorship available for Principal level).
• Expertise in medical device regulatory standards (FDA 21 CFR Part 820, ISO 13485, ISO 14971).

Nice to have

• Experience with test method development and Design for Six Sigma (DFSS) principles.
• Background in pre-clinical evaluations and system requirements development.
• Practical knowledge of project management and statistical data analysis.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA/FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short-term/long-term disability leave.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and global well-being programs.