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Medical Device Test Engineer Jobs in California (NOW HIRING)

Heartflow

Senior Test Engineer

San Francisco, CA · On-site

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 ...

MiniMed

Principal Test Engineer/Test Lead

Los Angeles, CA

$51.25 - $69.75/hr

The Principal Test Engineer acts as a trusted advisor to engineering and business leadership ... Mobile & Connected Medical Device Testing * Lead testing activities for mobile applications across ...

MiniMed

Principal Test Engineer/Test Lead

Northridge, CA · On-site

$51 - $69.50/hr

The Principal Test Engineer acts as a trusted advisor to engineering and business leadership ... Mobile & Connected Medical Device Testing * Lead testing activities for mobile applications across ...

DensityAI

Hardware Test Engineer

Mountain View, CA

$230K - $290K/yr

... interface, not ATE silicon device test) * Develop and run board-level test -- functional ... Additional compensation: equity grant per company guidelines; medical / dental / vision; 401(k) ...

Abbott

Staff Software Test Engineer

Alameda, CA · On-site

We are seeking a Senior Software Test Engineer to lead verification and validation efforts across ... Strong expertise in medical device V&V, including defect management and requirements traceability

DensityAI

Hardware Test Engineer

Mountain View, CA · On-site

$230K - $290K/yr

... device test) * Develop and run board-level test - functional, structural (boundary scan/JTAG), in ... Additional compensation: equity grant per company guidelines; medical / dental / vision; 401(k) ...

Abbott

Senior Software Test Engineer

Alameda, CA · On-site

$125K - $162K/yr

We are seeking a Software Test Engineer to lead verification and validation efforts across our cloud, and mobile platforms within a regulated medical device environment. This role is based in Alameda ...

Masimo

Engineer, Software Test

Irvine, CA · On-site

$80K - $100K/yr

Design and develop comprehensive test strategies, plans, and test cases for medical device systems ... Mentor junior engineers and provide technical leadership in test methodologies Minimum ...

Efficient Computer

Test Engineer

San Jose, CA

$150K - $190K/yr

Characterize device behavior across voltage, temperature, and frequency corners * Support load ... Serve as the primary test engineering interface with OSAT partners and test houses * Manage test ...

Efficient Computer

Test Engineer

San Jose, CA · On-site

Characterize device behavior across voltage, temperature, and frequency corners * Support load ... Serve as the primary test engineering interface with OSAT partners and test houses * Manage test ...

Aerotek

Medical Device Assembler

Irvine, CA

$19 - $23.25/hr

Use computers and software to connect devices via Bluetooth and run tests as part of the assembly ... Minimum of 2 years of medical device assembly experience, preferably in a clean room environment.

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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 are popular job titles related to Medical Device Test Engineer jobs in California? For Medical Device Test Engineer jobs in California, the most frequently searched job titles are:
What job categories do people searching Medical Device Test Engineer jobs in California look for? The top searched job categories for Medical Device Test Engineer jobs in California are:
What cities in California are hiring for Medical Device Test Engineer jobs? Cities in California with the most Medical Device Test Engineer job openings:
Medical Device Test Engineer jobs near you
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.

Senior Test Engineer

Heartflow

San Francisco, CA • On-site

Full-time

Re-posted 27 days ago

HeartFlow rating

7.8

Company rating: 7.8 out of 10

Based on 10 frontline employees who took The Breakroom Quiz

136th of 242 rated software companies

Job description

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
The Senior Test Engineer is a hands-on individual contributor on the Test Engineering team, responsible for end-to-end system testing, post-deployment verification, and the design and execution of automated test suites that protect the quality of our regulated SaMD products. Working under the technical direction set by the Test Architect, this role takes primary ownership of building out automated coverage across HeartFlow's pipeline from the ML/AI algorithms and clinical computation services through the Workstation, web applications, and reporting layers while applying the rigor required of a medical device environment. This role also plays a key part in scaling the team, supporting and coordinating offshore/contractor test engineers as HeartFlow's automation program grows. The ideal candidate brings deep technical expertise in modern UI automation frameworks (Selenium and Playwright), experience writing test plans and validating tools under a QMS, and a track record of shipping high-quality software in a regulated SaMD context.
Responsibilities
  • Design, implement, and maintain end-to-end (E2E) automated test suites that exercise complete user workflows across UI, API, and back-end services, executing against the architecture and standards set by the Test Architect.
  • Champion an AI-first automation strategy. Implement and scale test coverage using AI-assisted authoring and generative test planning derived from AI-generated requirements, while leveraging intelligent triage to minimize maintenance overhead.
  • Build and own a baseline suite of daily smoke/build-acceptance tests covering core workflows across development and staging environments, closing a current gap where automated testing only runs during formal V&V cycles.
  • Lead post-deployment testing activities, including production smoke tests, monitoring-driven verification, and continuous validation against live environments.
  • Design and implement golden-dataset regression tests for HeartFlow's ML pipeline services, validating algorithmic outputs against curated reference cases.
  • Build automated test coverage for HeartFlow's WebGL-based 3D Web Viewer and Clinical/CaseOps UIs using Playwright, including visual regression for 3D model rendering and view generation.
  • Author clear, traceable test plans, test protocols, and test reports that meet the documentation expectations of a regulated medical device QMS.
  • Perform tool validation for test infrastructure and automation tooling in accordance with internal QMS procedures and applicable standards.
  • Build and maintain UI automation using Selenium and Playwright; extend frameworks for stability, parallelism, and reuse across product lines.
  • Collaborate with software engineering teams to standardize API-level and integration tests using tools such as REST Assured, Postman, or Karate, including testing for DICOM ingestion and HL7 output validation at the hospital/cloud boundary.
  • Partner with software engineers, product managers, and RA/QA to translate requirements into verifiable test cases with full traceability, contributing to closing the current gap between code commits and Ketryx-generated audit evidence.
  • Triage and root-cause failures across complex distributed systems; drive defects to resolution and contribute to defect-prevention initiatives.
  • Contribute to CI/CD pipelines so that automated tests run reliably and provide fast, actionable feedback to engineering teams.
  • Support quality-related audits, CAPAs, and regulatory submissions by providing test evidence, traceability, and documentation.
  • Support and coordinate offshore/contractor test engineers for overlapping product areas, helping ramp them on HeartFlow's systems and test standards.
  • Mentor the Test Engineer role and contribute to hiring as the team scales.

Qualifications
  • 5-8 years of experience in software test engineering, SDET, or quality engineering roles, with a strong hands-on automation background.
  • Required: Direct experience testing Software as a Medical Device (SaMD) or other regulated medical device software.
  • Required: Working knowledge of medical device QMS practices and applicable standards (e.g., ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820), including test documentation, traceability, and tool validation.
  • Required: Strong proficiency with Selenium / WebDriver and Playwright, including framework design, page-object patterns, and stability/flake reduction techniques.
  • Demonstrated experience designing and maintaining E2E automation frameworks that cover complete workflows and system integrations.
  • Experience authoring test plans, protocols, and reports in a regulated environment, with attention to traceability between requirements, test cases, and evidence.
  • Practical experience with AI-assisted testing tools and techniques (e.g., AI-augmented test authoring, self-healing automation, LLM-driven test generation or triage).
  • Solid programming skills in Python and at least one additional mainstream language used for automation (e.g., TypeScript/JavaScript, Java, or C#).
  • Experience with API testing tools (REST Assured, Postman, Karate, Pact.io or equivalent) and basic familiarity with contract testing concepts.
  • Experience integrating automated tests into CI/CD pipelines (e.g., GitHub Actions, Harness) and working with cloud environments such as AWS.
  • Strong analytical and debugging skills across distributed systems, with a structured approach to root-cause analysis.
  • Excellent written and verbal communication skills; able to clearly document test designs, defects, and risk.
  • Bachelor's degree in Computer Science, Engineering, or a related field, or equivalent practical experience.

Desired
  • Direct experience with requirements/traceability tooling such as Ketryx, Jama, or Polarion.
  • Experience with DICOM and/or HL7 protocols, or other clinical data interoperability standards.
  • Experience supporting RA/QA teams during regulatory audits and inspections.
  • Experience testing ML/AI systems, clinical validation workflows, or medical imaging products, including statistical or tolerance-based regression approaches.
  • Experience validating complex visualizations (qualitative and quantitative) such as 3D models, overlays, or measurement views.
  • Experience generating and managing diverse test datasets (synthetic, anonymized, adversarial).
  • Experience coordinating or mentoring offshore or contractor test engineers.
  • Familiarity with non-functional / performance testing tools (e.g., k6, Locust, JMeter, Gatling).
  • Exposure to data-pipeline testing and microservices architectures.
  • Contributions to defining and tracking actionable quality metrics.

A reasonable estimate of the base salary compensation range is $165,000 to $205,000, bonus, and equity. #LI-IB1
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with "@heartflow.com" and B) the position described is found on our careers site at www.heartflow.com/about/careers/.

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