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Quality In Medical Devices Jobs (NOW HIRING)

Helen of Troy

$84K - $100K/yr

Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and ... Perform component and system failure analysis with Quality. * Lead technical reviews and ...

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ASK Consulting

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Quality Operations Specialist I (cur_1_131017@curatelyai.net)

Irvine, CA · On-site

$25 - $35/hr

Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance ... Bachelor's Degree in Electrical Engineering or Mechanical Engineering HIGHLY PREFERRED. Other ...

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Helen of Troy

NY · On-site

$84K - $100K/yr

Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and ... Perform component and system failure analysis with Quality. * Lead technical reviews and ...

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Caraballo Consulting & Associates L

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QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect ...

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Quality In Medical Devices information

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How much do quality in medical devices jobs pay per year?

As of Sep 14, 2026, the average yearly pay for quality in medical devices in the United States is $91,047.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,500.00 and $110,000.00 per year, depending on experience, location, and employer.

EMI/EMC Test Engineer Medical Devices

Newark, DE • On-site

Tekfortune Inc.
Recruiting and Staffing Services • 11 - 50 employees
Learn more about Tekfortune Inc.external

Other

Posted 3 days ago

New

Job description

EMI/EMC Test Engineer — Medical Devices

Department: Hardware Engineering / Regulatory & Compliance
Location: Glasgow, DE USA
Employment Type: Full-Time / Contract

Job Summary

We are seeking an EMI/EMC Test Engineer to own electromagnetic compatibility and electromagnetic interference testing for our medical device portfolio, ensuring compliance with IEC 60601-1-2 and supporting FDA/international regulatory submissions. The role works closely with R&D, systems engineering, and regulatory affairs to identify and mitigate EMC risks throughout the design lifecycle, particularly for devices operating in clinical and home-use environments.

Key Responsibilities

  • Plan, execute, and analyze EMC pre-compliance and full-compliance testing per IEC 60601-1-2 (radiated/conducted emissions, radiated/conducted immunity, ESD, EFT/burst, surge, magnetic field immunity, dips & interruptions)
  • Apply collateral/particular standards as applicable (e.g., IEC 60601-1-11 for home healthcare environments, IEC 60601-2-XX device-specific standards)
  • Support wireless coexistence testing for connected medical devices (BLE, Wi-Fi) per FDA guidance on RF wireless technology
  • Conduct EMC design reviews at schematic, PCB layout, cable/harness, and enclosure stages — especially around patient-connected circuits and isolation boundaries
  • Debug EMI/EMC failures using spectrum analyzers, EMI receivers, near-field probes, ESD simulators, and surge/EFT generators
  • Coordinate with accredited third-party test labs (e.g., UL, TÜV, Intertek) for formal IEC 60601-1-2 certification testing
  • Author and maintain EMC test plans, protocols, and reports suitable for FDA 510(k)/PMA submissions and CE technical files (MDR)
  • Link EMC test results to risk management file (ISO 14971) — document hazards, mitigations, and residual risk related to electromagnetic disturbances
  • Recommend and validate design mitigations (shielding, filtering, grounding, isolation) without compromising patient safety or essential performance
  • Support root-cause investigation for field complaints or CAPAs related to EMC issues
  • Maintain traceability between EMC test evidence and Design History File (DHF) per IEC 62304/design control requirements
  • Track evolving global regulatory requirements (FDA, EU MDR, Health Canada, etc.) affecting EMC for medical devices

Required Qualifications

  • Bachelor's degree in Electrical/Biomedical Engineering or related field
  • 3–7 years of EMI/EMC experience, with at least 2+ years specific to medical devices
  • Working knowledge of IEC 60601-1-2 and its test methods (IEC 61000-4 series as applied to medical devices)
  • Understanding of "essential performance" and "basic safety" concepts as they relate to EMC pass/fail criteria
  • Experience with EMC test equipment: EMI receivers, spectrum analyzers, ESD guns, surge/EFT/burst generators, near-field probes
  • Ability to read schematics/PCB layouts, particularly isolation barriers and patient-applied parts
  • Strong technical writing skills for regulatory-grade documentation

Preferred Qualifications

  • Experience supporting FDA 510(k) or PMA submissions, or EU MDR technical documentation
  • Familiarity with ISO 14971 (risk management) and IEC 62304 (software lifecycle, if device includes firmware)
  • Experience with wireless coexistence testing for connected/IoT medical devices
  • Exposure to home-use/lay-person environment EMC (IEC 60601-1-11)
  • Familiarity with EMC simulation tools (ANSYS HFSS, CST)

Soft Skills

  • Comfortable working within a regulated, design-controlled environment (documentation discipline, traceability)
  • Strong cross-functional collaboration with regulatory affairs, quality, and systems engineering
  • Able to communicate EMC risk clearly to non-EMC stakeholders (e.g., regulatory, clinical teams)
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About Tekfortune

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Our IT staffing services help companies customize business applications, develop software, manage their IT Infrastructure, and design and engineer technology products. Through our quality workforce solutions, we introduce technology professionals that are the correct match for our clients. Partner with Us Today

Industry

Recruiting and staffing services

Company size

11 - 50 Employees

Headquarters location

Piscataway, NJ, US

Year founded

2014

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