Lead Design Quality Engineer

• Location 3529 Anderson Street,Madison, WI, 53704,United States

Description

The Lead Design Quality Engineer owns design-control quality engineering for Neu Wave Medical's microwave ablation probe and console portfolio. This role partners with R&D and Regulatory Affairs to ensure design inputs, outputs, verification, validation, and design risk management activities meet FDA QSR, ISO 13485, and EU MDR requirements across new product development and sustaining design changes.

• Own the QA role in design control activities — managing the Design and Development File (DDF), which fulfills the traditional Design History File (DHF) role, across New Product Development (NPD) and sustaining design changes.
• Maintain the Risk Management Plan, Risk Management Report, and Risk Management File, and facilitate design risk management activities (FMEA, risk analysis) in accordance with ISO 14971.
• Participate on the Design Review Team (DRT), confirming design deliverables are complete, verified, and meet applicable regulatory and quality standards before progressing through phase gates.
• Ensure design verification and validation testing is conducted per approved plans and results are documented in the DDF.
• Review and approve engineering change orders affecting device design; identify regulatory requirements and applicable standards across outsourced design activities.
• Partner with R&D, Regulatory Affairs, and Manufacturing Engineering on design transfer and design change control.
• Support Computer System Validation (CSV) activities for systems supporting design and quality processes.
• Support internal and external audits related to design controls, including hosting regulatory and Notified Body auditors as needed.

• Bachelor's degree in Engineering or a related technical field (or equivalent combination of education and experience).
• 5+ years of quality engineering experience at a medical device manufacturer, with a focus on design controls and/or NPD.
• Working knowledge of ISO 13485, 21 CFR 820, and ISO 14971.
• Demonstrated experience with internal and/or external quality audits.
• Proficient with standard office software (Microsoft Office suite or equivalent).

• Experience hosting Notified Body/Registrar auditors or FDA investigators during on-site inspections is a plus.
• Experience with eQMS platforms, specifically Compliance Quest, is a plus.
• Prior CSV/software validation experience.

Less than 10%.

Work is primarily performed in an office and light-manufacturing/lab environment at Neu Wave Medical's Madison, WI facility. Requires the ability to sit or stand for extended periods, use a computer workstation, and occasionally lift up to 25 lbs. Reasonable accommodations will be made for individuals with disabilities to perform essential job functions.

Neu Wave Medical (a Precision IO Group company) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other status protected by applicable law.