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Medical Device Validation Engineer Jobs in Seattle, WA

VOLT

Medical Device Electronic Assembler

Seattle, WA · On-site

$27 - $31/hr

Collaborate with engineering and quality assurance teams to implement process improvements and ... in medical device manufacturing or another regulated manufacturing environment with part ...

Valspec

Validation Engineer (CSV)

Seattle, WA

Lead Validation Engineer (CSV / DeltaV) Valspec | Seattle, WA Full-Time | Hybrid Client Site ... Premium medical coverage * 401(k) with company match * Tuition reimbursement * Unique performance ...

Valspec

Validation Engineer (CSV)

Redmond, WA

Lead Validation Engineer (CSV / DeltaV) Valspec | Seattle, WA Full-Time | Hybrid Client Site ... Premium medical coverage * 401(k) with company match * Tuition reimbursement * Unique performance ...

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All JobsMedical Device Validation Engineer JobsMedical Device Validation Engineer Jobs in Seattle, WA

Medical Device Validation Engineer information

See Seattle, WA salary details

$25

$59

$88

How much do medical device validation engineer jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for medical device validation engineer in Seattle, WA is $59.17, according to ZipRecruiter salary data. Most workers in this role earn between $44.86 and $71.92 per hour, depending on experience, location, and employer.

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.

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 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 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 popular job titles related to Medical Device Validation Engineer jobs in Seattle, WA?

For Medical Device Validation Engineer jobs in Seattle, WA, the most frequently searched job titles are:

What job categories do people searching Medical Device Validation Engineer jobs in Seattle, WA look for?

The top searched job categories for Medical Device Validation Engineer jobs in Seattle, WA are:

What cities near Seattle, WA are hiring for Medical Device Validation Engineer jobs?

Cities near Seattle, WA 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 Seattle, WA as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 93% Physical, 1% Hybrid, and 6% Remote job distribution, with an average salary of $123,080 per year, or $59.2 per hour.

Design Engineer (Medical Device)

S-Solutions Inc- a SyeDyn Company

Bothell, WA • On-site

Other

This job post has expired 2 days ago. Applications are no longer accepted.

Job description

Design Quality Engineer

Work location: USA (Bothell/Cambridge)


The Design Quality Engineer (DQE) is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role works closely with R&D, regulatory, manufacturing, and suppliers to embed quality into product design.

Design Control

  • Ensure compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) throughout product lifecycle
  • Participate in design planning, design reviews, and design verification/validation activities. (cross-functional design reviews, ensuring closure of action items)
  • Review and approve design inputs, outputs, and technical documentation.
  • Support traceability matrix (DHF, DMR, DHR) creation and maintenance.
  • Ensure Design Verification & Validation (V&V) activities meet requirements
  • Review and approve, Engineering Change requests/Orders (ECR/ECOs).
  • Ensure design changes follow proper change control processes.
  • Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross-functional teams, ensuring alignment with quality standards and successful project milestones.
  • Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
  • Design transfer to manufacturing, ensuring process readiness

  • Risk Management Support

    • Guide comprehensive risk management activities throughout the product lifecycle to ensure risks are identified and mitigated
    • Facilitate FMEA (Design and Process) and hazard analysis.
    • Ensure risk controls are implemented, verified, and documented.


    QMS Support (Audit, CAPA)

    • Ensure preparation for quality audits and inspections, maintaining documentation to demonstrate compliance
    • Record, manage, and execute CAPA processes including root cause analysis and implementation of solutions
    • Contributes to the development, implementation, and revision of QMS processes


    Minimum required Education:

    Bachelor's Degree in Medical Sciences, Healthcare Management, Biomedical Engg’


    Minimum required Experience:

    • Knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MDR), Canadian Medical Devices Regulation (SOR/98-282), etc
    • Change Management (Including design and Manufacturing transfer)
    • Minimum of 5+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk
    • You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability


    Apply