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60601 Jobs in Michigan (NOW HIRING)

Product Safety Engineer

Portage, MI · On-site

$69K - $110K/yr

IEC 60601-1 (Medical Electrical Equipment Safety) * IEC 60601-1-2 (Electromagnetic Compatibility) * IEC 60529 (Ingress Protection) * IEC 61000 Series (EMC Testing) * IEC 61010-1 * ISO 17025 ...

Product Safety Engineer

Grand Rapids, MI · On-site

$69K - $110K/yr

IEC 60601-1 (Medical Electrical Equipment Safety) * IEC 60601-1-2 (Electromagnetic Compatibility) * IEC 60529 (Ingress Protection) * IEC 61000 Series (EMC Testing) * IEC 61010-1 * ISO 17025 ...

Support initiatives for product development teams with the technical understanding of 60601 and other required safety standards during the design & development of medical devices. * Positively ...

Support initiatives for product development teams with the technical understanding of 60601 and other required safety standards during the design & development of medical devices. * Positively ...

Support initiatives for product development teams with the technical understanding of 60601 and other required safety standards during the design & development of medical devices. * Positively ...

Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance Requirements) and/or IEC 62304 (Medical Device Software Lifecycle Requirements) preferred. * Strong familiarity with the ...

Preferred Qualifications: • Familiarity with IEC 14708 and 45502 Active Implantable standards • Familiarity with IEC 60601 Electrical Medical Equipment standards • Experience in Test Fixture ...

Experience with functional safety and regulatory standards such as ISO 26262, IEC 61508, DO‑178C/DO‑297, IEC 62304, ISO 14971, or IEC 60601, including partitioning and interference requirements.

Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance Requirements) and/or IEC 62304 (Medical Device Software Lifecycle Requirements) preferred. * Strong familiarity with the ...

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60601 information

What are 60601 standards?

The 60601 standards refer to the IEC 60601 series, which are international standards for the safety and performance of medical electrical equipment. These standards ensure that medical devices meet essential requirements for safety, reliability, and electromagnetic compatibility. Compliance with IEC 60601 is often required for medical devices to be marketed and used in hospitals and healthcare settings. The standards cover various aspects, including basic safety, essential performance, and specific requirements for different types of medical equipment.

What are the key skills and qualifications needed to thrive as a medical device quality engineer (IEC 60601 compliance), and why are they important?

To thrive as a Medical Device Quality Engineer specializing in IEC 60601 compliance, you need a solid background in biomedical engineering or a related field, along with knowledge of regulatory standards for medical electrical equipment. Familiarity with compliance testing tools, risk management software, and quality systems such as ISO 13485 is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for ensuring product safety and collaborating across teams. These abilities are crucial for maintaining regulatory compliance and ensuring the safety and effectiveness of medical devices in the healthcare industry.

What are common challenges faced by professionals working with IEC 60601 compliance, and how can they be addressed?

Professionals involved in IEC 60601 compliance often face challenges such as staying up-to-date with evolving standards, ensuring thorough documentation, and coordinating across departments like engineering and regulatory affairs. Addressing these challenges typically involves ongoing training, implementing robust project management tools, and fostering open communication among cross-functional teams. Regular internal audits and collaboration with external testing labs can also help ensure compliance and reduce the risk of costly redesigns or certification delays.

What is the difference between 60601 vs Medical Equipment Technician?

Aspect60601Medical Equipment Technician
CertificationsOften requires compliance with IEC 60601 standards, but not a specific certificationTypically requires certification in medical equipment repair or biomedical technology
Work EnvironmentHospitals, clinics, medical device manufacturingMedical facilities, repair shops, biomedical departments
Industry UsageStandards for medical electrical equipment safetyMaintains and repairs medical devices

While 60601 refers to safety standards for medical electrical equipment, Medical Equipment Technicians focus on repairing and maintaining such devices. Understanding 60601 is essential for technicians to ensure compliance and safety in their work.

What cities in Michigan are hiring for 60601 jobs?

Cities in Michigan with the most 60601 job openings:

Infographic showing various 60601 job openings in Michigan as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

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

Stark Pharma Solutions Inc

Michigan Center, MI • On-site

Contractor

Posted 4 days ago


Job description

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.