Lead Design Quality Engineer - Medical Devices & NPD

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

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