Principal Design Assurance Engineer

VDyne, Inc.; Osseo (MN); On-site; USD 140,000 - 160,000; Full time

Job summary

VDYNE, Inc. in Minneapolis, MN, seeks a Principal Design Assurance Engineer to lead design controls, risk management, verification and validation, and design transfer from concept through post-market.

You will be the senior DA Quality representative embedded in cross-functional teams and act as the technical authority on design controls and V&V. Ideal candidates have 10+ years in Quality Engineering within medical devices, with Class III experience and strong ISO 13485, FDA QMSR, and EU MDR

Qualifications

• 10+ years of progressive experience in Quality Engineering, Design Assurance, or product development in the medical device industry.
• Experience supporting Class III medical device development under formal design controls.
• Strong working knowledge of ISO 13485, FDA QMSR, EU MDR, and ISO 14971.
• Ability to effectively challenge technical decisions while maintaining collaborative working relationships.

Responsibilities

• Serve as the senior DA Quality representative on product development teams, reviewing and approving design control deliverables including design plans, inputs, outputs, V&V, design transfer, and design changes.
• Lead Quality oversight of risk management activities per ISO 14971, including hazard analyses, dFMEAs, uFMEAs, and pFMEAs.
• Provide Quality oversight of V&V strategies, protocols, test methods, and reports, reviewing for appropriate acceptance criteria, statistical rationale, and traceability to requirements and risks.
• Oversee design transfer quality activities and support post-market surveillance infrastructure, maintaining the Quality connection between clinical study safety data and the risk management file.
• Mentor Quality Engineers in DA practices and serve as the internal technical authority on design controls, risk management, and V&V methodology.

Skills

Quality Engineering

Regulatory Affairs

Risk Management

V&V

Leadership

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Quality Engineering, or related discipline

Job description

WHY VDYNE

VDYNE is a clinical-stage medical device company focused on developing innovative transcatheter valve solutions for tricuspid regurgitation (TR), a life-threatening condition. With its patented side-delivery technology, VDYNE enables minimally invasive procedures, expanding treatment options for TR patients. Headquartered in Minneapolis, Minnesota, VDYNE is actively conducting clinical studies across the United States, Europe, and Australia.

The company's mission is to transform patient outcomes through groundbreaking advancements in medical technology. This position will be instrumental in helping VDYNE achieve these ambitious goals.

THE ROLE

As Principal Design Assurance Engineer at VDYNE, you'll serve as a senior Quality representative embedded in our cross-functional product development teams, ensuring that design controls, risk management, verification and validation, and design transfer activities are executed with rigor and regulatory readiness from concept through post-market.

This role sits at the intersection of Quality and R&D, with a dotted line into the R&D function, and is ideal for a seasoned candidate who thrives as a technical authority, is comfortable challenging design decisions constructively, and is motivated by the opportunity to build quality infrastructure that directly enables a life-changing therapy to reach patients.

What You'll Do

Design Assurance & Design Controls

• Serve as the senior DA Quality representative on product development teams, reviewing and approving 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

Risk Management

• Lead Quality oversight of risk management activities per ISO 14971, including hazard analyses, dFMEAs, uFMEAs, and pFMEAs
• Support maintenance of the Risk Management File and Report across the product lifecycle

Design Verification & Validation

• Provide Quality oversight of V&V strategies, protocols, test methods, and reports, reviewing for appropriate acceptance criteria, statistical rationale, and traceability to requirements and risks

Design Transfer & Post-Market

• Oversee design transfer quality activities and support post-market surveillance infrastructure, maintaining 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

Regulatory & Compliance

• Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, and EU MDR; support regulatory submissions, audits, inspections, and Notified Body assessments

Mentorship & Leadership

• Mentor Quality Engineers in DA practices and serve as the internal technical authority on design controls, risk management, and V&V methodology

WHAT WE'RE LOOKING FOR

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Quality Engineering, or 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

Preferred

• Master's degree in Engineering, Quality, Regulatory Affairs, or 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

What Makes This Role Different

You’ll be joining at a pivotal moment as VDYNE is actively enrolling patients in IDE and CE Mark studies, which means the design assurance and risk management infrastructure you build and own here has a direct and immediate connection to patient safety and program success. This is a small, mission-driven quality team where your technical authority is genuine, your contributions are visible to leadership, and the work you do every day matters to patients who currently have very few treatment options.

Compensation & Benefits

VDYNE offers a competitive compensation package including base salary commensurate with experience, annual performance bonus, and equity participation. Benefits include medical, dental, and vision insurance; HSA with employer contribution; 401(k) with company match; paid time off; paid holidays; life and disability insurance; and professional development support.

In accordance with Minnesota pay transparency requirements, the anticipated salary range for this role is $140,000 – $160,000 annually, depending on experience and qualifications.

VDYNE, Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable law.