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Systems Complaince Engineer
2 weeks ago
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: Oakville- Hybrid
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.
What You'll Do
In this role, you will become a core contributor within our Sustaining Systems Engineering team. Your work will directly support global regulatory compliance, international product registrations, and the continuous improvement of our medical device platforms.
You will:
- 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.
Travel:
Up to 25 percent.
What You Bring
You thrive in fast-moving environments, can navigate complex systems, and enjoy the unique challenge of ensuring medical devices meet global compliance standards.
Required Education And Experience
- 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.
Technical And Professional Skills
- Experience troubleshooting EMI and EMC issues.
- Strong understanding of IEC safety and IEC 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.
- Project management experience is a plus.
Compensation and Benefits:
Along with a competitive salary and bonus structure, Natus offers a comprehensive healthcare package that starts on your first day of employment, paid statutory holidays, 3 weeks' vacation and 7 sick days, RRSP Match, and tuition reimbursement program eligibility.
Be the People part of the Neuro Solution. Apply Today.
EEO Statement:
Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status. This posting is for an existing vacancy.
