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Medical Device Test Engineer Jobs in California (NOW HIRING)

System Test Engineer

Irvine, CA · On-site

$110 - $130/hr

A System Test Engineer will become familiar with applicable international standards associated with medical device development and quality management (ISO 13485, ISO 14971, IEC 62304, and IEC 62366 ...

Embedded within the Quality organization, System Test Engineering roles provide independent technical verification and validation of complex medical device systems while working closely with Systems ...

Embedded within the Quality organization, System Test Engineering roles provide independent technical verification and validation of complex medical device systems while working closely with Systems ...

System Test Engineer

Irvine, CA · On-site

$110 - $130/hr

Embedded within the Quality organization, System Test Engineering roles provide independent technical verification and validation of complex medical device systems while working closely with Systems ...

System Test Engineer

Irvine, CA · On-site

$110 - $130/hr

Embedded within the Quality organization, System Test Engineering roles provide independent technical verification and validation of complex medical device systems while working closely with Systems ...

New

The Senior Test Engineer is a hands-on individual contributor on the Test Engineering team ... Working knowledge of medical device QMS practices and applicable standards (e.g., ISO 13485, IEC ...

Senior Test Engineer Location : Pleasanton CA Experience: 6+ Years Key Responsibilities * Design ... Comply with regulatory requirements and documentation standards for Medical Device IT systems (e.g ...

Test Engineer Location : Irvine, CA Duration : Full-time / Contract : * Experience in Embedded ... Medical Device Experience is an advantage * BS in Electrical & Electronics Engineering ...

The ideal candidate brings a strong technical engineering foundation, hands-on testing experience, and the ability to clearly document and communicate test results within a regulated medical device ...

Senior Test Engineer

San Francisco, CA · On-site

$140 - $180/hr

Working knowledge of medical device QMS practices and applicable standards (e.g., ISO 13485, IEC ... Experience in Software Test Engineering * Direct experience with Software as a Medical Device (SaMD)

A System Test Engineer will become familiar with applicable international standards associated with medical device development and quality management (ISO 13485, ISO 14971, IEC 62304, and IEC 62366 ...

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Medical Device Test Engineer information

What does a medical device test engineer do?

A Medical Device Test Engineer is responsible for designing, developing, and executing tests to ensure that medical devices meet regulatory standards and function safely and effectively. They create test plans, perform verification and validation activities, and analyze test data to identify potential issues. Their work is crucial to ensure that devices are reliable and compliant with industry regulations before reaching the market.

What are the key skills and qualifications needed to thrive as a medical device test engineer?

To thrive as a Medical Device Test Engineer, you need a solid background in biomedical engineering or a related field, strong analytical skills, and a deep understanding of medical device regulations such as FDA and ISO standards. Familiarity with test automation tools, data acquisition systems, and software like LabVIEW or MATLAB is typically required, along with certifications such as ISTQB or Six Sigma being advantageous. Strong attention to detail, problem-solving abilities, and effective communication are essential soft skills for collaborating with cross-functional teams and documenting results. These skills and qualifications ensure that medical devices are safe, effective, and compliant with regulatory standards, ultimately protecting patient health.

What are some common challenges faced by medical device test engineers during product validation, and how are they typically addressed?

Medical Device Test Engineers often encounter challenges such as ensuring compliance with stringent regulatory standards (like FDA or ISO), managing tight project timelines, and troubleshooting complex device failures during validation. Addressing these challenges usually involves thorough documentation, close collaboration with cross-functional teams (such as design, quality, and regulatory), and implementing robust test protocols. Regular communication and proactive risk assessment also help anticipate potential issues and maintain project momentum.

What is the difference between Medical Device Test Engineer vs Quality Assurance Engineer?

AspectMedical Device Test EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like ISTQB or ISO 13485 familiarityEngineering or related degree, ISO 9001/13485 certifications often preferred
Work EnvironmentLaboratories, manufacturing facilities, R&D settingsQuality departments, manufacturing plants, compliance offices
Industry UsageFocuses on testing medical devices for safety and functionalityEnsures overall quality management and compliance processes

Medical Device Test Engineers primarily focus on testing and validating medical devices to ensure safety and performance, often working closely with R&D and manufacturing teams. Quality Assurance Engineers oversee broader quality systems, compliance, and process improvements. While both roles aim to ensure product safety, the Test Engineer concentrates on device testing, whereas the QA Engineer manages quality systems and standards compliance.

What cities in California are hiring for Medical Device Test Engineer jobs?

Cities in California with the most Medical Device Test Engineer job openings:

Infographic showing various Medical Device Test Engineer job openings in California as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 12% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

CRA Device Test Engineer

Element Materials Technology

Fremont, CA • On-site

$160K/yr

Other

Posted 17 days ago


Element Materials Technology rating

7.3

Company rating: 7.3 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

74th of 120 rated laboratories


Job description

CRA Device Test Engineer
Job Locations US-CA-Fremont
ID 2026-19853
Overview

Element is seeking a CRA Device Test Engineer to join our lab in Fremont, CA. Element offers end-to-end product Cybersecurity testing and certification services to ensure your IoT product is safe, secure and compliant with PSTI, RED, and CRA. In this role, you will design and implement highly secure technical solutions to protect against cyber threats and potential cyber-attacks.

If you are not currently authorized to work in the US without sponsorship, Element Materials Technology will not consider your job application. Any candidate must be lawfully eligible to work in the US as a US Citizen or Permanent Resident of the United States.

Salary range: $120 - 160K/year

Responsibilities
    Detailed working knowledge of EN 303 645, EN18031 (series) and other relevant cybersecurity test standards
  • Maintain 'state-of-art-art' knowledge of product-based cybersecurity requirements within Element Materials Technology and ensure this information is shared and trained across the business
  • Provide cybersecurity assessments of products to ensure they meet the applicable standards
  • Provide training and mentoring of cybersecurity test engineers to ensure that they become and maintain competent for testing of cybersecurity to the applicable standards
  • Create and maintain cybersecurity test procedures against the applicable standards and ensure that the appropriate requirements of ISO 17025 are met
  • Technically lead and support cybersecurity test audits from external and internal parties
  • Be technically competent with sufficient training and experience of cyber security principles as it relates to equipment; and have sound technical and vocational training
  • Attend customer meetings to provide technical support in regards to technical queries relating to project status or affecting progress
  • To provide occasional technical support to the Commercial team (e.g. Sales Applications Engineers) to assist in the preparation of quotations specific to cyber security
  • To ensure that commercial confidentiality is maintained
  • To carry out any other reasonable duty as directed by the line manager
Skills / Qualifications
  • Relevant Degree or equivalent, plus minimum 5 years' experience
  • A highly self-motivated individual with positive mindset & can-do attitude, and a strong believer of "Security as an enabler" to support business growth
  • Strong intellectual agility, with the ability to apply it to a wide range of business contexts
  • Experience with EN 18031 and ETSI EN 303 645 cybersecurity standards for connected devices, including risk assessment, vulnerability management, and compliance for EU market access
  • Confident ability to write and review designs, reports, procedures and standards
  • Experience with EU Cyber Resilience Act (CRA) is a plus
  • Must possess strong communicative skills and the ability to translate technical findings to a non-technical audience

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Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 7,500 brilliant minds operating from 200 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

Diversity Statement

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.


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