Natus Medical Incorporated · 6 hours ago
Systems Compliance Engineer
Middleton, WI
Full-time
Hybrid
Senior Level
$90K/yr - $110K/yr
5+ years expNatus Medical Incorporated is a company that has been delivering innovative neuro solutions for over 80 years. As a Systems Compliance Engineer, you will ensure that Natus products meet global safety and regulatory standards while working on complex medical devices and collaborating with international testing labs.
BiotechnologyMedical DeviceHealthcareHealth CareHealth DiagnosticsMedical
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
Qualification
Required
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
Preferred
Project management experience is a plus
Benefits
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
Company
Natus Medical Incorporated
Natus Medical Incorporated (Natus) offers medical equipment, software, supplies and services for the diagnosis, monitoring, and treatment of impairments and disorders effecting the brain, neural pathways, and eight sensory nervous systems.
1001-5000 employees
H1B Sponsorship
Natus Medical Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (12)
2023 (12)
2022 (7)
2021 (7)
2020 (10)
Funding
Current Stage
Public CompanyTotal Funding
$30.76MKey Investors
ROTH Capital Partners
2022-04-18Acquired
2006-08-24Post Ipo Equity· $30.76M
2001-07-20IPO
Leadership Team
James Hawkins
CEO
Recent News
2026-01-08
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2025-10-07
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