Systems Compliance Engineer

Natus • Middleton, WI

5d • $90,000 - $110,000 • Hybrid

About The Position

FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals.

Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.
Location: Hybrid (Middleton, WI)
Join a team that powers the next generation of neurodiagnostic and medical electrical systems used around the world. As a Systems Compliance Engineer, you will play a key role in ensuring Natus products meet the highest global standards for safety, reliability, and regulatory excellence. This is a hands-on engineering role, where every day brings a new challenge, whether you're working directly with cutting-edge medical devices, solving EMC mysteries in the lab, or partnering with international test labs to bring compliant products to market.
If you love complex systems, enjoy diving into technical problems, and want to make an impact on medical technology used by clinicians and patients worldwide, this is your opportunity.

Requirements

• Bachelor’s degree in an engineering field with at least 5 years of relevant experience, or
• Master’s degree in engineering with at least 3 years of relevant experience, or
• An equivalent combination of education and experience.
• Experience troubleshooting EMI and EMC issues.
• Strong understanding of IEC 60601-1 safety and IEC 60601-1-2 EMC requirements and testing.
• Familiarity with FDA, CFDA, and EU regulatory environments including design history files and technical files.
• Knowledge of medical device technology, quality standards, and safety regulations.
• Ability to manage multiple projects in a fast-paced environment with high ambiguity.
• Experience using product lifecycle management (PLM) tools.
• Strong analytical thinking, creativity, and attention to detail.
• Clear and confident communication of technical concepts.

Nice To Haves

• Project management experience is a plus.

Responsibilities

• Debug EMI and EMC issues in the lab to achieve passing compliance results with minimal design changes on already marketed electrical medical devices.
• Interface with third-party testing labs, traveling as needed to support compliance testing and communicate design intent.
• Quickly learn and understand the architecture of Natus neurodiagnostic systems to troubleshoot issues with limited global support.
• Conduct, guide, and achieve compliance of products to applicable international safety standards and regulations.
• Identify and implement improvements to our compliance engineering processes using modern industry approaches.
• Support product compliance testing and type testing including safety, EMI/EMC, reliability, and environmental testing.
• Participate in standards gap assessments and identify required documentation updates or additional product testing.
• Raise engineering change requests (ECRs), update design history files, and coordinate with regulatory affairs on technical file updates.
• Manage follow-up services with certification labs such as ETL and UL.
• Contribute to other core systems engineering activities such as risk management, usability engineering, and requirements development.
• Update or inactivate safety reports and manage third-party safety inspection nonconformances.
• Provide guidance and training across the organization on regulatory standards, EMC debugging, and compliance engineering best practices.
• Support long-term harmonization of Natus device platforms through shared architectures, reusable components, and consistent design and test methodologies.

Benefits

• Natus offers generous compensation and benefits packages including health benefits, 401k contribution, 7 paid holidays + 2 floating holidays of your choosing, generous paid time off, tuition reimbursement assistance program, eligibility for performance-based bonuses or commissions, where applicable and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level