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Medical Device Validation Engineer Jobs in Virginia

Cadence Inc

Validation Engineer II

Staunton, VA · On-site

$83K - $105K/yr

... medical device and other advanced industries. We're an engineering company at heart--with over 75 ... We are seeking a highly motivated Validation Engineer onsite at one of our five sites: Cranberry ...

Danaher

Sales Representative Medical Device

Richmond, VA · On-site +1

$90K - $100K/yr

... in a medical device industry preferred * 1+ years capital equipment sales experience preferred ... Must have a valid driver's license and a clean driving record for the last 3 years * Ability to ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... to medical, dental, vision, and prescription drug coverage - ensuring you and your family stay ...

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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.

What engineers make $500,000?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can reach or exceed a $500,000 annual salary, especially with experience, advanced skills, and leadership roles. Medical Device Validation Engineers typically earn less, but senior-level professionals with extensive expertise and certifications may approach high six-figure incomes in certain industries or companies.

How much does a validation engineer make at Pfizer?

A validation engineer at Pfizer typically earns between $70,000 and $100,000 annually, depending on experience, location, and certifications. Salaries may also include benefits such as health insurance and bonuses, with some roles requiring knowledge of validation protocols and regulatory standards.

Are validation engineers in demand?

Validation engineers, including those in the medical device industry, are in high demand due to strict regulatory requirements and the need for quality assurance. Their skills in validation protocols, risk management, and compliance with standards like ISO 13485 and FDA regulations make them valuable in manufacturing and quality assurance roles across healthcare and biotech sectors.

Do validation engineers make good money?

Validation engineers, including those in the medical device industry, typically earn competitive salaries that vary based on experience, location, and certifications. They often require knowledge of regulatory standards and validation tools, which can influence compensation levels. Overall, validation engineering is considered a well-paying profession within engineering fields.

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, and why are they important?

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

Validation Engineer II

Cadence Inc

Staunton, VA • On-site

$83K - $105K/yr

Full-time

Re-posted 12 hours ago

Job description

At Cadence, we improve product performance by building solution-oriented partnerships with our customers and delivering highly technical, measurable outcomes across medical device and other advanced industries.

We’re an engineering company at heart—with over 75 engineers across our organization—and have built a legacy of over three decades of manufacturing excellence by doing what others consider impossible.

Position Overview:
We are seeking a highly motivated Validation Engineer onsite at one of our five sites: Cranberry Twp., Sturgeon Bay, WI, Suffield, CT, Staunton, VA or Cranston, RI sites, to lead and support validation activities across multiple projects at our facility.

This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and manufacturing teams.

Key Responsibilities:

  • Develop and execute validation protocols. (IQ, OQ, PQ, TMV)
  • Maintain detailed validation documentation. (VMPs, reports, SOPs)
  • Conduct risk assessments and manage change controls.
  • Ensure regulatory compliance. (GMP, GLP, CSV, data integrity)
  • Collaborate cross-functionally to support validation strategy and training.
  • Monitor system performance and lead requalification activities.
  • Qualify suppliers and vendors.
  • Contribute to process improvements and continuous improvement initiatives.

Qualifications:

  • Bachelor’s in Engineering, Life Sciences, or related field.
  • 3+ years' experience in validation or quality in a regulated industry.
  • Knowledge of FDA, ISO 13485, 21 CFR Part 820 standards.
  • Proficiency in Microsoft Suite; experience with validation software.
  • Strong communication, documentation, and analytical skills.
  • Preferred: Lean/Six Sigma certification; experience with LMS systems.

Work Environment:
Split between office and production floor. Requires clear communication, computer use, and occasional physical movement around facility.

Travel requirement amongst sites up to 50% total.

Consistent with Cadence's career architecture, this position may be staffed at varying experience levels. Criteria evaluated when determining level and compensation is based on experience, skills, and other job-related factors.

We are not offering sponsorship at this time for this position.