Senior Design Quality Engineer – Medical Devices

NeuWave Medical Inc.; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

NeuWave Medical Inc. is seeking a Lead Design Quality Engineer to own design-control quality for our 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 across development and sustaining changes. The role emphasizes DDF/DHF ownership, risk management per ISO 14971, design verification/validation, and cross-functional collaboration to drive

Qualifications

• Bachelor's degree in Engineering or a related technical field is required or equivalent combination of education and experience.
• 5+ years of quality engineering experience at a medical device manufacturer, with 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).

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.

Skills

Quality engineering

Design controls

NPD experience

Audits

Office software

Education

Bachelor's degree in Engineering or related field

Job description

NeuWave Medical Inc. is seeking a Lead Design Quality Engineer to own design-control quality for our 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 across development and sustaining changes. The role emphasizes DDF/DHF ownership, risk management per ISO 14971, design verification/validation, and cross-functional collaboration to drive