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Medical Device Validation Engineer Jobs in California

Crown Medical, Inc.

Medical Device Rep

Carlsbad, CA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Bausch+Lomb Companies Inc.

$65K - $100K/yr

The Medical Device Engineer II supports the design and development of contact lenses within Bausch ... Track record of contributing to product launches or design verification/validation activities

Altera

Software Validation Engineer

San Jose, CA · On-site

Experience with embedded systems, operating systems (Linux/Windows), and device drivers is highly ... medical condition, genetic information, military and veteran status, marital status, pregnancy ...

New

Bachem

Validation Engineer

Vista, CA · On-site

$103K - $142K/yr

A brief overview The Quality Engineer (QE) / Validation fulfills a critical role in GMP operations ... comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid ...

Bachem

Validation Engineer

Vista, CA · On-site

$103K - $142K/yr

A brief overview The Quality Engineer (QE) / Validation fulfills a critical role in GMP operations ... comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid ...

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Medical Device Validation Engineer information

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

Are medical device validation engineers in demand?

Medical device validation engineers are in high demand due to the increasing regulation and complexity of medical devices. They play a critical role in ensuring compliance with standards like ISO 13485 and FDA requirements, and their expertise in validation, testing, and quality assurance is sought after in the healthcare industry.

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

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

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

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.
What are popular job titles related to Medical Device Validation Engineer jobs in California? For Medical Device Validation Engineer jobs in California, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in California look for? The top searched job categories for Medical Device Validation Engineer jobs in California are:
What cities in California are hiring for Medical Device Validation Engineer jobs? Cities in California with the most Medical Device Validation Engineer job openings:
Medical Device Validation Engineer jobs near you
Infographic showing various Medical Device Validation Engineer job openings in California as of August 2026, with employment types broken down into 67% Full Time, 6% Temporary, and 27% Contract. Highlights an 95% In-person, and 5% Remote job distribution.

Software Validation Engineer

Altera Corporation

San Jose, CA • On-site

$133K - $192K/yr

Full-time

Posted 4 days ago

Job description

Job Details:
Job Description:
Altera is seeking a motivated Software Validation Engineer to ensure the quality and reliability of our cutting-edge software solutions for programmable logic devices!
Responsibilities:
  • Design, develop, and execute comprehensive test plans and test cases for software components and systems, including drivers, tools, and IDEs.
  • Automate testing processes using scripting languages (e.g., Python, Perl, Bash) and established testing frameworks.
  • Identify, document, and track software defects using bug tracking systems.
  • Collaborate closely with software development, hardware design, and applications engineering teams to understand product requirements and ensure testability.
  • Analyze test results, generate reports, and present findings to stakeholders.
  • Develop and maintain test environments, including hardware setups and software configurations.
  • Participate in design reviews and provide feedback on software architecture and design for testability.
  • Contribute to the continuous improvement of validation processes and methodologies.
  • Stay current with industry best practices in software testing and validation.

The pay range below is for Bay Area California only. Actual salary may vary based on a number of factors including job location, job-related knowledge, skills, experiences, trainings, etc. We also offer incentive opportunities that reward employees based on individual and company performance.
$133.2K - $192.8K USD
We use artificial intelligence to screen, assess, or select applicants for the position. Applicants must be eligible for any required U.S. export authorizations.
Qualifications:
  • Bachelor's or Master's degree in Computer Engineering, Electrical Engineering, Computer Science, or a related field.
  • 3+ years of experience in software validation, quality assurance, or testing.
  • Strong understanding of software development life cycles (SDLC) and various testing methodologies.
  • Proficiency in at least one scripting language (e.g., Python, Perl, Tcl).
  • Experience with defect tracking systems (e.g., Jira, Bugzilla).
  • Familiarity with version control systems (e.g., Git, Perforce).
  • Knowledge of hardware description languages (Verilog/VHDL) and FPGA design flows is a plus.
  • Experience with embedded systems, operating systems (Linux/Windows), and device drivers is highly desirable.
  • Excellent problem-solving skills and attention to detail.
  • Strong written and verbal communication skills.
  • Ability to work independently and as part of a collaborative team.

Job Type:
Regular
Shift:
Shift 1 (United States of America)
Primary Location:
San Jose, California, United States
Additional Locations:
Posting Statement:
All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance.

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