Job Title: Sr Product Safety Engineer
Location: Portage, MI (3-4 days ONSITE)
Duration: 6 months
Ideal Start Date: Aug 10th
Background or Drug Screen required: Yes
Project Details: Support a third-generation medical device/product currently undergoing UL certification and verification testing, with a focus on electrical product safety, V&V, EMC, and regulatory compliance activities. The immediate priority is assisting with final testing execution, documentation, and certification reporting under IEC/ISO 60601 (3rd Edition). The consultant will also provide compliance and regulatory input for an early-stage second-generation product program. Most testing is performed internally, with some testing conducted at UL's Northbrook, IL facility.
· Define and implement product safety program plans for complex device development programs.
· Create product safety test plans and ensure they meet third-party certifier requirements.
· Support lab personnel on compliance testing, design conformance, and product safety issues.
· Interface with Nationally Recognized Test Labs (NRTLs) and external bodies to achieve product certification.
· Apply design controls, change controls, and risk management per the Quality Management System.
· Partner within design teams to drive product safety, compliance, and industry best practices.
· Mentor and support early-career engineers in the product safety discipline (as needed).
Musts:
Hands-on IEC/ISO 60601 3rd Edition testing experience
Strong electrical product safety testing background
Verification & Validation (V&V) experience
EMC testing and compliance experience
Experience supporting UL and/or CSA certification activities
Ability to execute testing, analyze results, and prepare technical reports
5–10 years of relevant experience (targeting approximately 7–8 years)
Pluses:
Former UL or CSA test engineer experience
Product Safety Engineer background
Regulatory Affairs and compliance experience
Experience supporting medical device development programs
Experience with both testing execution and regulatory strategy
Familiarity with next-generation product development and design planning activities
Prior work in accredited test lab environments (UL, CSA, or similar)
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