Electrical Compliance Engineer – Medical Device (IEC/ISO 60601, EMC, V&V)

This role focuses on electrical product safety, V&V, EMC, and regulatory compliance activities, with immediate priority on final testing execution, documentation, and certification reporting under IEC/ISO 60601 (3rd Edition). Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States.

Job Description:

ABOUT COMPANY:

Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.

Electrical Compliance Engineer Medical Device (IEC/ISO 60601, EMC, V&V)

JOB SUMMARY:

Our client, a medical device manufacturer, is seeking an Electrical Compliance Engineer to support a third-generation medical device currently undergoing UL certification and verification testing. This role focuses on electrical product safety, V&V, EMC, and regulatory compliance activities, with immediate priority on 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.
This is a hands-on product-safety testing role. Candidates whose background is limited to general quality/documentation work, without direct UL/CSA test-lab or hands-on 60601 testing experience, will not be a fit.

RESPONSIBILITIES:

• 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

QUALIFICATIONS:

• 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
• Direct experience supporting UL and/or CSA certification activities
• Former UL or CSA test engineer, or Product Safety Engineer background, strongly preferred
• Regulatory affairs and compliance experience specific to medical devices
• Experience with both testing execution and regulatory strategy
• Prior work in an accredited test lab environment (UL, CSA, or similar)
• 5 10 years of relevant experience (targeting 7 8 years)
• Must be legally authorized to work in the United States
• W2 employment only

HOW TO APPLY:

Please send your resume to

deepika.b@starkpharma.com

. In your email, please include your current location, your hourly rate expectation on W2, and your availability to start.