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Medical Device Test Engineer Jobs in California (NOW HIRING)

... and medical device systems. This role is responsible for defining test requirements, driving Design for Test (DFT) methodologies, developing test strategies, designing automated test equipment ...

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... a medical device QMS. This is the founding technical hire for Heartflow's Test Engineering function, responsible for architecting the end-to-end testing framework across frontend, backend, 3D ...

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Senior Mechanical Engineer - Medical Device San Diego, CA (Onsite) 130,000-180,000 DOE Join a ... What you'll do: · Design and improve precision mechanical components, assemblies, and test ...

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Job Title: Software/Firmware Test Engineer Duration: 12+ Months (Possible extension) Location ... a class III medical device. * Responsible for developing, applying and maintaining quality ...

... and medical device systems. This role is responsible for defining test requirements, driving Design for Test (DFT) methodologies, developing test strategies, designing automated test equipment ...

New

Design and build test systems to evaluate device performance, safety, and reliability with ... A degree in an engineering discipline (mechanical, electrical, mechatronics, engineering physics ...

Design and build test systems to evaluate device performance, safety, and reliability with ... A degree in an engineering discipline (mechanical, electrical, mechatronics, engineering physics ...

Hiring 5 Medical Device Assemblers for a Catheter Medical Device Company in Santa Clara, CA ... It is unlawful in Massachusetts to require or administer a lie detector test as a condition of ...

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Medical Device Test Engineer information

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 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 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 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 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, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Hardware Test Engineer

Jj

Santa Clara, CA

Full-time

Retirement, PTO

Posted 3 days ago

New


Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Hardware Test Engineer

We are seeking a Hardware Test Engineer with exceptional drive to lead the development, validation, and deployment of manufacturing test solutions for complex electromechanical, robotic, and medical device systems. This role is responsible for defining test requirements, driving Design for Test (DFT) methodologies, developing test strategies, designing automated test equipment, creating software solutions, managing external vendors, validating test systems, and deploying scalable manufacturing test processes. our next-generation surgical robotics platforms.

Why This Role Matters: This role offers the opportunity to shape manufacturing test strategy early in the product lifecycle, preventing costly delays and ensuring our products can scale while meeting the highest quality standards. The ideal candidate combines strong systems engineering, hardware design, software development, and manufacturing expertise with the ability to lead cross-functional programs and influence product architecture to ensure robust, scalable, and cost-effective test solutions.

Key Responsibilities

Requirements Development

  • Translate PRD/PRDO and business requirements into manufacturing test, equipment, and process requirements.
  • Decompose system requirements into PCBA, subsystem, software, equipment, and manufacturing test requirements.
  • Maintain requirements traceability and identify testability risks early in product development.

Design for Test (DFT)

  • Lead DFT reviews at PCBA, subassembly, subsystem, system, and software levels.
  • Define diagnostic strategies, fault isolation methods, and test coverage requirements.
  • Collaborate with design teams to improve testability, manufacturability, and serviceability.

Test Strategy & Process Development

  • Develop test strategies for EVT, DVT, PVT, validation, and production.
  • Establish test coverage, release criteria, and manufacturing readiness plans.
  • Create test methods, procedures, calibration plans, failure workflows, and continuous improvement initiatives.

Test Equipment Development

  • Define test equipment specifications and acceptance criteria.
  • Design and develop electrical, mechanical, and software test solutions.
  • Select and implement appropriate hardware and software platforms, including PXI, LabVIEW, Python, PLCs, vision systems, and MES-integrated solutions.
  • Lead equipment development from concept through production release.

Software Development

  • Develop and maintain automated test software, data acquisition systems, diagnostics, and reporting tools.
  • Integrate test systems with MES, databases, and manufacturing analytics platforms.

Vendor & Project Management

  • Manage suppliers and system integrators, including SOW development, technical reviews, contract support, and acceptance testing.
  • Lead project schedules, budgets, risks, and deliverables for outsourced equipment development.

Validation & Deployment

  • Develop validation plans including MSA, GR&R, correlation studies, FAT, and SAT.
  • Deploy test systems into manufacturing and support pilot builds, product launches, and global factory transfers.
  • Monitor yield, throughput, uptime, and overall test performance to drive continuous improvement.

Qualifications

Education

  • BS or MS in Electrical Engineering, Computer Engineering, Mechanical Engineering, Systems Engineering, or related field.

Experience

0 - 2 years in hardware test engineering, manufacturing test engineering, or automated test equipment development.

Technical Skills

  • Requirements development and systems engineering
  • DFT and test architecture development
  • Automated test equipment design
  • Electrical, mechanical, and software development
  • Python, LabVIEW, or equivalent test software platforms
  • Validation methodologies (MSA, GR&R, FAT, SAT)
  • MES integration, data analysis, and manufacturing process development
  • Vendor and project management. undefined

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center(ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource

#LI-Onsite

Required Skills:

Preferred Skills:

Analytical Reasoning, Artificial Intelligence (AI), Controls Compliance, Execution Focus, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Project Management, Prototyping, Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Scope Management, Smart Systems, Systems Development, Technologically Savvy, Testing

The anticipated base pay range for this position is :

$91,000.00 - $147,200.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
The following link to general company benefits information MUST also be included in the posting: Please use the following language:
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits