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Medical Device Validation Engineer Jobs in Raleigh, NC

Valspec

Validation Engineer

Raleigh, NC

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

Valspec

Validation Engineer

Holly Springs, NC

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

Integrated Resources INC

Validation Engineer

Durham, NC · On-site

Experience in a sterile or pharmaceutical environment is required but will consider other FDA -- cGMP experience and medical device or combination product production Performed validation of Quality ...

Novartis

Validation Engineer III

Durham, NC · On-site

$183K/yr

As a Validation Engineer III, you will play a critical role in bringing manufacturing systems to ... If, because of a medical condition or disability, you need a reasonable accommodation for any part ...

GlaxoSmithKline

Senior Device Quality Engineer

Zebulon, NC

$75K - $101K/yr

... validation, and maintaining Design and Development Files (DDF) related to medical devices ... Experience with human factors engineering, design controls, and device risk management (e.g., ISO ...

GSK

Senior Device Quality Engineer

Zebulon, NC · On-site

$75K - $101K/yr

... validation, and maintaining Design and Development Files (DDF) related to medical devices ... Experience with human factors engineering, design controls, and device risk management (e.g., ISO ...

GlaxoSmithKline

Device Engineer

Zebulon, NC · On-site

Maintain a strong level of validation understanding and proficiencies within life cycle management ... Experience with design controls, risk management and quality processes used in medical device ...

GSK

Device Engineer

Zebulon, NC · On-site

Maintain a strong level of validation understanding and proficiencies within life cycle management ... Experience with design controls, risk management and quality processes used in medical device ...

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 ...

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All JobsMedical Device Validation Engineer JobsMedical Device Validation Engineer Jobs in Raleigh, NC

Medical Device Validation Engineer information

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

As of Jul 12, 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 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 Raleigh, NC? For Medical Device Validation Engineer jobs in Raleigh, NC, the most frequently searched job titles are:
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
Infographic showing various Medical Device Validation Engineer job openings in Raleigh, NC as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $105,133 per year, or $50.5 per hour.

Validation Engineer

Validation & Engineering Group, Inc

Holly Springs, NC

Full-time

Re-posted 28 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.