Act as the local expert for IEC 60601-2-37, IEC 60601-1, IEC 60601-1-2, and related ultrasound safety standards, providing authoritative interpretation and ensuring compliance across design and ...
Act as the local expert for IEC 60601-2-37, IEC 60601-1, IEC 60601-1-2, and related ultrasound safety standards, providing authoritative interpretation and ensuring compliance across design and ...
Senior Electrical Engineer - Pleasanton, CA
Pleasanton, CA · On-site
$119K - $155K/yr
Ensure EMI/EMC robustness and compliance with applicable medical standards (e.g., IEC 60601-1-2). * Select sensor, actuator, power electronics, and protection components for controls systems with ...
Senior Electrical Engineer - Pleasanton, CA
Pleasanton, CA · On-site
$119K - $155K/yr
Ensure EMI/EMC robustness and compliance with applicable medical standards (e.g., IEC 60601-1-2). * Select sensor, actuator, power electronics, and protection components for controls systems with ...
Strong familiarity with IEC 60601 testing is essential to the role. Essential functions: - Performs engineering validation testing / electrical testing - Familiarity with requirements management ...
Strong familiarity with IEC 60601 testing is essential to the role. Essential functions: - Performs engineering validation testing / electrical testing - Familiarity with requirements management ...
IEC 60601-1-2 for EMC, IEC 60601-1-6 for usability, IEC 60601-1-11 for home healthcare environments) * ISO 14971 - Risk Management for Medical Devices * ISO 13485 - Quality Management Systems * IEC ...
IEC 60601-1-2 for EMC, IEC 60601-1-6 for usability, IEC 60601-1-11 for home healthcare environments) * ISO 14971 - Risk Management for Medical Devices * ISO 13485 - Quality Management Systems * IEC ...
Sr Electrical Engineer - Exempt
Lafayette, CO · On-site
$60 - $70/hr
G., IEC 60601). * Develop detailed specifications, schematics, and PCB layouts, collaborating closely with cross-functional teams to meet design and performance requirements. * Ensure reliability ...
Sr Electrical Engineer - Exempt
Lafayette, CO · On-site
$60 - $70/hr
G., IEC 60601). * Develop detailed specifications, schematics, and PCB layouts, collaborating closely with cross-functional teams to meet design and performance requirements. * Ensure reliability ...
Ensure compliance with IEC 60601 standards and other regulatory requirements. * Develop and execute validation strategies and advanced test techniques for amplifiers, antennas, and high-frequency ...
Ensure compliance with IEC 60601 standards and other regulatory requirements. * Develop and execute validation strategies and advanced test techniques for amplifiers, antennas, and high-frequency ...
Sr. Electrical Engineer
Burlington, MA · On-site
$117K - $152K/yr
Familiarity with IEC 60601-1, IEC 60601-1-2 , and other applicable electrical safety and EMC standards. * Excellent analytical, problem-solving, and cross-functional collaboration skills. #GKOSUS ...
Sr. Electrical Engineer
Burlington, MA · On-site
$117K - $152K/yr
Familiarity with IEC 60601-1, IEC 60601-1-2 , and other applicable electrical safety and EMC standards. * Excellent analytical, problem-solving, and cross-functional collaboration skills. #GKOSUS ...
Sr. Electrical Engineer
Burlington, MA · On-site
$117K - $152K/yr
Familiarity with IEC 60601-1, IEC 60601-1-2 , and other applicable electrical safety and EMC standards. * Excellent analytical, problem-solving, and cross-functional collaboration skills. #GKOSUS ...
Sr. Electrical Engineer
Burlington, MA · On-site
$117K - $152K/yr
Familiarity with IEC 60601-1, IEC 60601-1-2 , and other applicable electrical safety and EMC standards. * Excellent analytical, problem-solving, and cross-functional collaboration skills. #GKOSUS ...
Sr. Electrical Engineer
Burlington, MA · On-site
$117K - $152K/yr
Familiarity with IEC 60601-1, IEC 60601-1-2 , and other applicable electrical safety and EMC standards. * Excellent analytical, problem-solving, and cross-functional collaboration skills. #GKOSUS ...
Sr. Electrical Engineer
Burlington, MA · On-site
$117K - $152K/yr
Familiarity with IEC 60601-1, IEC 60601-1-2 , and other applicable electrical safety and EMC standards. * Excellent analytical, problem-solving, and cross-functional collaboration skills. #GKOSUS ...
Sr. Reliability Engineer
Lafayette, CO · Hybrid
$124K - $159K/yr
Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366. Navigate the complexities of various government and industry ...
Sr. Reliability Engineer
Lafayette, CO · Hybrid
$124K - $159K/yr
Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366. Navigate the complexities of various government and industry ...
Support IEC 60601-1 , IEC 60601-1-2 , IEC 80601-2-77 electrical safety/EMC compliance. * Collaborate on HW/SW integration and ensure compliance with IEC 62304/82304 . * Support supplier qualification ...
Support IEC 60601-1 , IEC 60601-1-2 , IEC 80601-2-77 electrical safety/EMC compliance. * Collaborate on HW/SW integration and ensure compliance with IEC 62304/82304 . * Support supplier qualification ...
Senior Electrical Engineering Manager
Round Lake, IL · On-site
$103K - $134K/yr
Ensure all designs meet regulatory and quality standards, including IEC 60601-1, 60601-1-2, 60601-2-24, FDA design control, and ISO 13485. * Define and maintain hardware/software interface ...
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Senior Electrical Engineering Manager
Round Lake, IL · On-site
$103K - $134K/yr
Ensure all designs meet regulatory and quality standards, including IEC 60601-1, 60601-1-2, 60601-2-24, FDA design control, and ISO 13485. * Define and maintain hardware/software interface ...
Sr. Reliability Engineer
Lafayette, CO · Hybrid
$124K - $159K/yr
Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366. Navigate the complexities of various government and industry ...
Sr. Reliability Engineer
Lafayette, CO · Hybrid
$124K - $159K/yr
Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366. Navigate the complexities of various government and industry ...
Sr Systems Analysis Engineer, Medical Devices
$96K - $132K/yr
Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971. * Ability to effectively work and communicate in technical cross ...
Quick apply
Sr Systems Analysis Engineer, Medical Devices
$96K - $132K/yr
Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971. * Ability to effectively work and communicate in technical cross ...
EMC-Safety EE Engineer
Lake Forest, CA · On-site
... IEC 60601-1, at least the first amendment, preferably both amendments; and the content of the fourth edition of IEC 60601-1-2, including the first amendment. This familiarity should also include ...
EMC-Safety EE Engineer
Lake Forest, CA · On-site
... IEC 60601-1, at least the first amendment, preferably both amendments; and the content of the fourth edition of IEC 60601-1-2, including the first amendment. This familiarity should also include ...
Compliance Engineer
Plano, TX · On-site
ISO 14708-1 * ISO 14708-3 * IEC 60601-1 * IEC 60601-1-2 * IEC 61000-4 Series Education Requirements * Bachelor's degree in Engineering or a related technical field (preferred)
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Compliance Engineer
Plano, TX · On-site
ISO 14708-1 * ISO 14708-3 * IEC 60601-1 * IEC 60601-1-2 * IEC 61000-4 Series Education Requirements * Bachelor's degree in Engineering or a related technical field (preferred)
Principal Electrical Engineer
Morrisville, NC · On-site
$130K - $159K/yr
Experience with EMC/EMI design practices and electrical safety standards (IEC 60601-1, IEC 60601-1-2). * Experience leading formal design reviews and presenting technical analyses to cross-functional ...
Principal Electrical Engineer
Morrisville, NC · On-site
$130K - $159K/yr
Experience with EMC/EMI design practices and electrical safety standards (IEC 60601-1, IEC 60601-1-2). * Experience leading formal design reviews and presenting technical analyses to cross-functional ...
Sr Systems Analysis Engineer, Medical Devices
Bloomington, IN · On-site
$96K - $132K/yr
Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971. * Ability to effectively work and communicate in technical cross ...
Sr Systems Analysis Engineer, Medical Devices
Bloomington, IN · On-site
$96K - $132K/yr
Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971. * Ability to effectively work and communicate in technical cross ...
Lead IEC 60601-1 compliance and regulatory testing, leveraging tools like HIPOT and Electrical Safety Analyzers * Partner with hardware, firmware, quality, and manufacturing teams to deliver high ...
Lead IEC 60601-1 compliance and regulatory testing, leveraging tools like HIPOT and Electrical Safety Analyzers * Partner with hardware, firmware, quality, and manufacturing teams to deliver high ...
Principal Electrical Engineer
$163K - $199K/yr
Ensure products meet: -IEC 60601-1 -IEC 60601-1-2 -IEC 62304 (system integration) -ISO 14971 * Support EMC, surge, ESD, EFT, and immunity testing. * Design mitigation strategies (MOVs, TVS, filters ...
Principal Electrical Engineer
$163K - $199K/yr
Ensure products meet: -IEC 60601-1 -IEC 60601-1-2 -IEC 62304 (system integration) -ISO 14971 * Support EMC, surge, ESD, EFT, and immunity testing. * Design mitigation strategies (MOVs, TVS, filters ...
60601 information
See salary details
$5.29 - $11.12
0% of jobs
$11.12 - $16.96
11% of jobs
$16.96 - $22.79
0% of jobs
$22.79 - $28.63
0% of jobs
$28.63 - $34.46
5% of jobs
$36.47 is the 25th percentile. Wages below this are outliers.
$34.46 - $40.30
25% of jobs
The median wage is $44.11 / hr.
$40.30 - $46.13
13% of jobs
$51.89 is the 75th percentile. Wages above this are outliers.
$46.13 - $51.97
21% of jobs
$51.97 - $57.80
12% of jobs
$57.80 - $63.64
4% of jobs
$63.64 - $69.47
8% of jobs
$5
$45
$69
How much do 60601 jobs pay per hour?
What are the key skills and qualifications needed to thrive as a Medical Device Quality Engineer (IEC 60601 compliance), and why are they important?
What are 60601 standards?
What are common challenges faced by professionals working with IEC 60601 compliance, and how can they be addressed?
What is the difference between 60601 vs Medical Equipment Technician?
| Aspect | 60601 | Medical Equipment Technician |
|---|---|---|
| Certifications | Often requires compliance with IEC 60601 standards, but not a specific certification | Typically requires certification in medical equipment repair or biomedical technology |
| Work Environment | Hospitals, clinics, medical device manufacturing | Medical facilities, repair shops, biomedical departments |
| Industry Usage | Standards for medical electrical equipment safety | Maintains 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.

Full-time
Posted 19 days ago
GE HealthCare rating
8.5
Based on 131 frontline employees who took The Breakroom Quiz
59th of 417 rated machine equipment manufacturers
Job description
The Lead Product Safety Engineer is responsible for ensuring the safety and regulatory compliance of products within the GE HealthCare Ultrasound Probes organization. This role ensures that safety requirements are defined, implemented, and verified throughout all phases of the product lifecycle. The Lead Product Safety Engineer partners closely with design engineering, risk management, quality, regulatory, and manufacturing teams to drive robust safety engineering practices, safeguard patient safety, and ensure compliance with product safety standards.
Job Description
Roles and Responsibilities
- Serve as a Subject Matter Expert (SME) and local technical authority for product safety of ultrasound probes, following and sharing best practices, and supporting global consistency across programs.
- Partner with the Safety & Risk Engineer and the local Install Base Engineer to apply ISO 14971 throughout the product lifecycle, covering hazard identification, risk analysis, risk control strategies, benefit-risk justification, and final safety sign-off. Maintain and update product Cause & Mitigation Tables (CMT) to ensure all mitigations remain effective and implemented, incorporating post-market feedback and periodic review inputs in a timely manner.
- Lead product-safety-related interactions with Notified Bodies (NB), including owning safety document submissions, preparing technical safety justifications, responding to NB questions or nonconformities, and representing product safety as a SME during NB audits and technical file reviews.
- Own the definition, flowdown, and verification of product safety requirements, ensuring they are appropriately incorporated during concept development, requirements definition, architecture decisions, NPI, design changes, and sustaining activities.
- Act as the local expert for IEC 60601-2-37, IEC 60601-1, IEC 60601-1-2, and related ultrasound safety standards, providing authoritative interpretation and ensuring compliance across design and verification activities.
- Drive resolution of safety-critical issues, including investigation of safety escalations, evaluation of field data, review of design changes, and leadership of cross-functional safety assessments and safety-impact decisions.
- Provide safety engineering leadership for audits, inspections, design reviews, and regulatory submissions, ensuring safety documentation is complete, accurate, and compliant with global regulatory expectations.
- Mentor and develop engineers and support personnel, building safety engineering capability through training, coaching, and technical guidance on standards, safety analyses, and test methodology.
- Monitor and interpret evolving global regulations and safety standards, assessing their impact on product development and work proactively with the Safety & Risk Engineer to integrate new requirements into organizational processes and designs.
Required Qualifications
- Bachelor's degree in engineering, physics, or related technical discipline and 5+ years of medical device development experience;
OR 10+ years in medical device engineering/compliance with at least 3 years of hands-on IEC compliance and safety testing experience. - Demonstrated expertise in IEC 60601 series, IEC 60601-2-37, IEC 60529, and other applicable medical electrical equipment standards.
- Strong working knowledge of ISO 14971, including experience leading or contributing to formal device risk management activities.
- Proven ability to lead cross-functional teams, influence technical decisions, and communicate complex safety concepts across diverse technical and cultural environments.
Desired Characteristics
- Experience in medical ultrasound, diagnostic imaging systems, or related high-reliability medical devices.
- Familiarity with GE HealthCare's QMS, design control processes, and product development workflows.
- Demonstrated ability to manage multiple priorities, drive complex technical issues to closure, and make sound safety-critical decisions under time constraints.
- Strong analytical, troubleshooting, and problem-solving skills, with the ability to distill complex information into clear technical documentation.
- Excellent written and verbal communication skills, including the ability to author safety justifications, risk-benefit analyses, and regulatory documentation.
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We will not sponsor individuals for employment visas, now or in the future, for this job opening.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
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