Principal Design Assurance Engineer

VDyne•Maple Grove, MN

11d•$140,000 - $160,000

About The Position

As Principal Design Assurance Engineer at VDYNE, you will serve as a senior Quality representative embedded in cross-functional product development teams. You will ensure that design controls, risk management, verification and validation, and design transfer activities are conducted rigorously and remain regulatory-ready from concept through post-market. The role sits at the intersection of Quality and R&D, with a dotted line into the R&D function. It suits a seasoned technical authority who can constructively challenge design decisions and build quality infrastructure that enables a life-changing therapy to reach patients. You will provide Quality oversight across design assurance, risk management, V&V, design transfer, post-market activities, and regulatory compliance. You will also mentor Quality Engineers and serve as an internal technical authority. VDYNE is actively enrolling patients in IDE and CE Mark studies, so the design assurance and risk management infrastructure developed in this role has a direct connection to patient safety and program success. The role is part of a small, mission-driven Quality team with visible contributions to leadership. VDYNE offers base salary commensurate with experience, an annual performance bonus, and equity participation. Benefits include medical, dental, and vision insurance; an HSA with employer contribution; a 401(k) with company match; paid time off and holidays; life and disability insurance; and professional development support. The anticipated salary range is $140,000–$160,000 annually, depending on experience and qualifications.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Quality Engineering, or a related discipline.
10+ years of progressive experience in Quality Engineering, Design Assurance, or product development in the medical device industry.
Significant experience supporting Class III medical device development under formal design controls.
Strong working knowledge of ISO 13485, FDA QMSR, EU MDR, and ISO 14971.
Strong understanding of design V&V, risk management, traceability, and design transfer.
Experience supporting regulatory submissions, inspections, or Notified Body audits.
Ability to effectively challenge technical decisions while maintaining collaborative working relationships.
Strong written and verbal communication skills.

Nice To Haves

Master's degree in Engineering, Quality, Regulatory Affairs, or a related discipline.
ASQ-CQE, CSSGB, CSSBB, or equivalent certifications.
Experience with catheter-based and/or tissue-based heart valve development.
Experience with CERs, PMCF activities, or post-market surveillance programs.
Experience supporting IDE pivotal studies or CE Mark clinical investigations.

Responsibilities

Serve as the senior Design Assurance Quality representative on product development teams and review and approve design control deliverables, including design plans, inputs, outputs, V&V, design transfer, and design changes.
Ensure design requirements are complete, measurable, testable, and traceable to user, clinical, safety, and regulatory requirements.
Lead Quality oversight of risk management activities under ISO 14971, including hazard analyses, dFMEAs, uFMEAs, and pFMEAs.
Support maintenance of the Risk Management File and Report across the product lifecycle.
Provide Quality oversight of V&V strategies, protocols, test methods, and reports, including review of acceptance criteria, statistical rationale, and traceability to requirements and risks.
Oversee design transfer quality activities.
Support post-market surveillance infrastructure and maintain the Quality connection between clinical study safety data and the risk management file.
Contribute to Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) plans.
Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, and EU MDR.
Support regulatory submissions, audits, inspections, and Notified Body assessments.
Mentor Quality Engineers in Design Assurance practices.
Serve as the internal technical authority on design controls, risk management, and V&V methodology.