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Medical Device Validation Engineer Jobs in Raleigh, NC

Valspec

Validation Engineer

Raleigh, NC

VALIDATION ENGINEER Location: Raleigh, NC (AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY ... Premium medical coverage * 401(k) with company match * Tuition reimbursement * Unique performance ...

Valspec

Equipment Validation Engineer

Raleigh, NC

GMP Equipment Validation Engineer - CQV Location: Raleigh, NC Position Overview: We are seeking a ... Premium medical coverage * 401(k) with company match * Tuition reimbursement * Unique performance ...

Danaher

Sales Representative Medical Device

Raleigh, NC · On-site

$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 ...

Danaher

Sales Representative Medical Device

Raleigh, NC · 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 ...

Merz North America

Senior Electrical Engineer

Raleigh, NC · On-site

$95K - $123K/yr

You will work hands-on in the lab to prototype, debug, and validate designs, while collaborating ... Master's Degree of engineering experience in the medical device industry and/or highly regulated ...

Merz North America

Senior Electrical Engineer

Raleigh, NC

$95K - $123K/yr

You will work hands-on in the lab to prototype, debug, and validate designs, while collaborating ... Master's Degree of engineering experience in the medical device industry and/or highly regulated ...

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Medical Device Validation Engineer information

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

As of Jun 11, 2026, the average hourly pay for medical device validation engineer in Raleigh, NC is $50.54, according to ZipRecruiter salary data. Most workers in this role earn between $38.32 and $61.44 per hour, depending on experience, location, and employer.

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 earn $500,000 or more annually, often through a combination of base salary, bonuses, and stock options. Achieving this level typically requires extensive experience, advanced skills, and sometimes leadership roles or working in high-paying industries.

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.

Do validation engineers make good money?

Validation engineers, including those in the medical device industry, typically earn competitive salaries that reflect their specialized skills in quality assurance, regulatory compliance, and testing. Salaries vary based on experience, location, and certifications such as GxP or ISO standards, but generally offer strong compensation compared to many entry-level roles. The profession often includes benefits like healthcare and opportunities for career advancement.

What engineers make $300,000 a year?

Senior medical device validation engineers with extensive experience, specialized skills in quality assurance, and certifications such as ISO 13485 can reach annual salaries of $300,000 or more. These roles often require advanced knowledge of regulatory standards, validation processes, and proficiency with testing tools in highly regulated environments.

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

Validation Engineer

Validation & Engineering Group, Inc

Holly Springs, NC

Full-time

Posted 27 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Validation Engineer

Description:

The role demands deep technical expertise across the full validation lifecycle — including URS development, FAT/SAT execution, and Computer System Validation (CSV) — as well as hands-on experience with systems and controls integration. The candidate will drive end-to-end project implementation: from equipment design and installation through startup, commissioning, and qualification.

Key Responsibilities:

  • Develop User Requirement Specifications (URS).
  • Lead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.
  • Drive process design for new equipment and ensure product design requirements are met.
  • Execute commissioning and qualification activities for new and existing equipment.
  • Provide technical oversight to ensure equipment meets safety, regulatory, and operational standards.
  • Manage suppliers and external vendors on capital projects, controlling scope, cost, and lead time.
  • Collaborate with Procurement and Legal on vendor contracts.
  • Create and maintain engineering documentation (URS, assembly instructions, bill of process, etc.).
  • Optimize equipment design for manufacturability, cost reduction, maintainability, and efficiency.
  • Lead design reviews, risk assessments, and FMEA to ensure reliability and performance.
  • Ensure compliance with all safety regulations and quality policies, procedures, and GMP standards.
  • Apply statistical analysis and SPC systems to support data-driven decision-making.
  • Manage multiple priorities and maintain equipment qualification schedules.

Qualifications:

  • Bachelor's degree in Engineering or Science.
  • Minimum 4 years of engineering experience in pharmaceutical and/or medical device industries.
  • Demonstrated experience across the full validation lifecycle (URS, FAT, SAT, CSV).
  • Proven track record supporting full project implementation: design, installation, startup, commissioning, and qualification.
  • Strong experience executing capital projects within GMP-regulated manufacturing environments.
  • Familiarity with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments.
  • Ability to work independently and lead solutions under general direction.
  • Strong organization, and communication skills

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.