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Iec 60601 Jobs (NOW HIRING)

NIRSense Inc

Senior Electrical Engineer

Morrisville, NC

$100K - $131K/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 ...

Intellectt INC

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)

Glaukos

Sr. Electrical Engineer

Burlington, MA

$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 ...

Glaukos

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 ...

Glaukos

Sr. Electrical Engineer

Burlington, MA

$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 ...

Jj

Principal Electrical Engineer

Santa Clara, CA

$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 ...

NIRSense Inc

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 ...

NIRSense Inc

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 ...

NIRSense Inc.

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 ...

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All JobsIec 60601 Jobs

Iec 60601 information

What are some of the common challenges faced by professionals working with IEC 60601 compliance in medical device development?

Professionals working with IEC 60601 compliance often face challenges related to interpreting complex safety and performance requirements, as well as keeping up with frequent updates to the standard. Ensuring comprehensive documentation and rigorous testing to meet both basic and collateral standards can be time-consuming. Collaboration with cross-functional teams, such as regulatory, engineering, and quality assurance, is essential to address issues early and streamline the approval process. Additionally, adapting designs to accommodate evolving regional regulations can be a significant challenge.

What is the difference between Iec 60601 vs Medical Equipment Technician?

AspectIec 60601Medical Equipment Technician
CertificationsMay require IEC 60601 compliance knowledgeTypically certified in medical equipment repair and maintenance
Work EnvironmentDesign, testing, and compliance of medical electrical devicesRepair, calibrate, and maintain medical equipment in healthcare settings
Industry UsageStandards for medical electrical devicesHands-on technical support in hospitals and clinics

IEC 60601 is a standard ensuring safety and performance of medical electrical equipment, while a Medical Equipment Technician focuses on maintaining and repairing such devices. The technician applies IEC 60601 standards in their work but is primarily involved in practical device support rather than standard development or compliance testing.

What are the key skills and qualifications needed to thrive as a Medical Device Compliance Engineer (IEC 60601), and why are they important?

To excel as a Medical Device Compliance Engineer specializing in IEC 60601, a solid background in electrical engineering, regulatory standards, and risk management is required, often supported by a relevant engineering degree. Familiarity with IEC 60601-1 standards, test equipment, and compliance management software is essential for the role. Strong attention to detail, analytical thinking, and effective communication are soft skills that help navigate complex regulatory requirements and cross-functional collaboration. These competencies ensure medical devices are safe, effective, and meet global regulatory standards for patient safety.

What is IEC 60601?

IEC 60601 is an international series of technical standards for the safety and essential performance of medical electrical equipment. It ensures that medical devices are safe for both patients and operators by addressing electrical, mechanical, and functional safety. Compliance with IEC 60601 is mandatory in many countries for manufacturers who want to market their medical devices. The standard is regularly updated to reflect new technological advances and safety requirements.
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Iec 60601 jobs near you
Infographic showing various Iec 60601 job openings in the United States as of June 2026, with employment types broken down into 94% Full Time, and 6% Contract. Highlights an 84% Physical, 6% Hybrid, and 10% Remote job distribution.

Senior Electrical Engineer

NIRSense Inc

Morrisville, NC

$100K - $131K/yr

Full-time

Posted 4 days ago

Job description

Minimum Qualifications:

  • 5+ years of experience in electrical engineering, with significant focus on medical devices or biomedical sensing systems.
  • Demonstrated ability to independently lead and deliver complex medical device hardware development projects from concept through design verification and validation.
  • Deep hands-on expertise with design and integration of electrical components of miniaturized medical device systems such as PCBs, PCB components, batteries, and light-emitting and detecting systems.
  • Expertise in mixed-signal circuit design for physiological sensing, including signal generators, amplifiers, filters, ADCs, and low-noise data acquisition systems.
  • Experience designing low-power architectures and battery management systems for body-worn medical devices.
  • 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 stakeholders in a design-controlled environment.
  • Proficiency in PCB design tools (Altium Designer preferred), including rigid, flex, and rigid-flex designs for space-constrained wearable form factors.
  • Strong technical writing skills, with experience authoring design documentation for regulated environments.
  • Experience managing PCB fabricator and contract manufacturer relationships, including vendor qualification and supply chain risk mitigation.
  • B.S. in Electrical or Biomedical Engineering or a related field.

Preferred Qualifications:

  • Knowledge of biosensing and electrical stimulation technologies and proficiency in hardware implementations of these technologies.
  • Experience with optoelectronic circuit design, including LED drivers, photodiode front-ends, and transimpedance amplifiers (TIAs).
  • Experience with mechanical-electrical integration for miniaturized wearable enclosures and collaboration with mechanical engineering teams.
  • Familiarity with C/C++ and embedded systems integration with BLE-enabled microcontrollers (e.g., Nordic nRF series) for wireless physiological data streaming.
  • Experience directing and reviewing work from external PCB layout and design contractors.
  • Experience designing medical wearable hardware for manufacturability (DFM) and testability (DFT), including development of test fixtures and validation systems.
  • Experience with design verification and validation (V&V) testing in a regulated medical device environment.
  • Experience supporting FDA regulatory submissions (e.g., 510(k), de novo) and familiarity with design controls under 21 CFR Part 820 or ISO 13485.
  • Experience with hardware FMEA and risk management per ISO 14971.

Job Responsibilities:

  • Design low-power architectures, battery charging circuits, and power budgets for portable and wearable device platforms.
  • Design for safety and electromagnetic compatibility (EMC/EMI), conduct pre-compliance testing, and support formal EMC and electrical safety testing per IEC 60601-1 and IEC 60601-1-2.
  • Drive and lead design reviews with multi-disciplinary stakeholders, establishing rigorous engineering practices and collaborating closely with firmware, mechanical, and software engineers to ensure seamless system integration.
  • Independently manage relationships with PCB fabricators and assemblers; oversee BOM cost, sourcing risk, and component lifecycle to supply finished, high-quality electronics.
  • Lead test fixture design and manufacturing test strategy, from prototype PCB evaluation through design transfer and production yield optimization.
  • Author and review technical reports, maintain schematic libraries and design history files (DHF), and contribute hardware FMEA and risk management files (ISO 14971) to support regulatory submissions (510(k), de novo).
  • Report to the Electrical Engineering R&D Manager.

About NIRSense

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

11 - 50 Employees

Headquarters location

Richmond, VA, US

Year founded

2018

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