Senior Design Assurance Engineer, Medical Devices

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

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