Lead Design Quality Engineer

Kids for the Future; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

NeuWave Medical in Madison, WI, seeks a Lead Design Quality Engineer to own design-control quality activities for its microwave ablation probe and console portfolio. You will partner with R&D and Regulatory Affairs to ensure inputs, outputs, verification, validation, and risk management meet FDA QSR, ISO 13485, and EU MDR requirements.

You will manage the DDF, risk management files, and participate in the Design Review Team, ensuring tests are conducted per plan and audits are prepared for

Qualifications

• 5+ years of quality engineering at a medical device manufacturer.
• Experience with design controls and NPD.
• Working knowledge of ISO 13485, 21 CFR 820, ISO 14971.
• Proven experience with internal and external audits.
• Proficient with Microsoft Office.

Responsibilities

• Own design-control activities across NPD and sustaining changes.
• Maintain the Design and Development File (DDF) and DHF.
• Manage Risk Management Plan, Report, and File per ISO 14971.
• Participate on the Design Review Team to ensure completions.
• Ensure design verification and validation testing per plans.
• Support CSV activities and audits with regulators.

Skills

Quality engineering

Design controls

Regulatory knowledge

Audits

Office software

Education

Bachelor's degree in Engineering

Tools

ComplianceQuest

Job description

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

Description

Position Summary

The Lead Design Quality Engineer owns design-control quality engineering for NeuWave 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.

Key Responsibilities

• 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.

Required Qualifications

• 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).

Preferred Qualifications

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

Travel Requirements

Less than 10%.

Work Environment & Physical Demands

Work is primarily performed in an office and light-manufacturing/lab environment at NeuWave 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.

NeuWave 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.