, ideal for a compliance professional who can support our engineering team during
product design reviews, pre-compliance evaluations, and certification preparation
.
Key Responsibilities
Provide
technical guidance
on IEC 60601-1 safety requirements and risk management (including clauses for mechanical, electrical, thermal, and leakage currents).
Advise and support engineering teams on
EMC testing per IEC 60601-1-2
, including emissions, immunity, and test setup.
Conduct
design reviews
and
gap analyses
to identify non-conformities early in the product development cycle.
Assist in creating and reviewing
test protocols, technical files, and documentation
required for regulatory submissions (FDA, ISO 13485, EU MDR, Health Canada).
Collaborate with external accredited laboratories (UL, Intertek, TUV, etc.) during formal compliance testing.
Provide
on-demand consulting
(remote or in person as needed) to troubleshoot compliance issues and propose design modifications.
Qualifications
Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or related field.
5+ years of hands-on experience
with
IEC 60601-1 electrical safety
and
IEC 60601-1-2 EMC
compliance testing.
Familiarity with additional standards (e.g., IEC 60601-2-22 for lasers, ISO 14971 for risk management) is a strong asset.
Proven track record of working with
medical device manufacturers
and test labs.
Strong technical documentation, analysis, and problem-solving skills.
Available on an
as-needed/on-call basis
with flexible hours.
What We Offer
Contract / on-demand engagement with
competitive hourly or project-based compensation
.
Opportunity to work with a
fast-growing, FDA-cleared medical device manufacturer
.
Remote collaboration with occasional on-site support (as required).
Flexible scheduling tailored to project needs.
Job Type: Casual
Pay: $20.00-$30.00 per hour
Work Location: In person
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