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Medical Device Validation Engineer Jobs in Raleigh, NC

Solesis

Product Development Engineer

Apex, NC · On-site

... medical device industry. Our range of materials and processing technologies allow us to provide ... The Product Development Engineer aids in the development, validation, and commercialization of ...

Polyzen LLC

Product Development Engineer

Apex, NC · On-site

... medical device industry. Our range of materials and processing technologies allow us to provide ... The Product Development Engineer aids in the development, validation, and commercialization of ...

Eisai, Inc.

Mgr., Product Complaints (Hybrid)

Raleigh, NC · On-site

$104K - $137K/yr

FDA Medical Device Reporting (21 CFR Part 803) * EU MDR vigilance and complaint handling requirements * ISO 14971 risk management principles * IEC 62366-1 usability engineering * Strong cross ...

Eisai

Mgr., Product Complaints (Hybrid)

Raleigh, NC · Hybrid

$104K - $137K/yr

FDA Medical Device Reporting (21 CFR Part 803) * EU MDR vigilance and complaint handling requirements * ISO 14971 risk management principles * IEC 623661 usability engineering * Strong cross ...

Teleflex

Sr. Packaging Engineer

Morrisville, NC · On-site

... validation of sterile and non-sterile packaging for medical products for the Global Teleflex ... Generate product, process, and experimental activity specifications for the Device Master Record as ...

Teleflex

Sr. Packaging Engineer

Morrisville, NC · On-site

Support process development, validation, and implementation activities within Teleflex ... Work with cross-functional teams to develop medical device packaging, specifications, and processes ...

Polyzen, LLC

Extrusion Development Engineer

Apex, NC

... medical device industry. Our range of materials and processing technologies allow us to provide ... development, validation, and commercialization of extruded films on machines such as Flat Die ...

Align Technology

Sr. R&D Engineer, New Products

Raleigh, NC · On-site

$101K - $139K/yr

Develop and execute verification and validation activities to assess product performance and design ... Experience in the medical device industry Pay Transparency If provided, base salary or wage rate ...

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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 Jun 13, 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.
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
Product Development Engineer

Product Development Engineer

Solesis

Apex, NC • On-site

Full-time

Medical, Retirement, PTO

Posted 11 days ago

Job description

Who we are:
Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle.
1st shift Monday-Friday 8:00 am-5:00 pm
About the role:
The Product Development Engineer aids in the development, validation, and commercialization of custom device components and assemblies, including ideation, prototyping, process optimization, qualification, and quality compliance. This role will partner with senior engineers to deliver Polyzen's product development processes to meet customer needs. The Product Development Engineer will engage with key internal operational stakeholders and grow their business acumen by working with our business development teams, vendors, and clients.
What you will do:
  • Support multiple projects for new product development in various stages of the product life cycle in line with agreed commitments to respective clients.
  • Communicate the status of development projects to internal stakeholders and leaders.
  • Assists in the design and manufacturing process to ensure scalability to a production environment based on customer design and volume requirements.
  • Aid in the identification of specific tooling, fixtures, and equipment for production purposes at the required scale and manufacturing throughput.
  • Partners with a cross-functional team to facilitate a transition of the manufacturing process from development groups to commercial groups while maintaining collaborative working relationships.
  • Responsible for documenting all development phases per the Polyzen product development process and quality compliance. Compile, maintain, review, and interpret product development data.
  • Review SOPs, work instructions, batch records, product specifications, process performance qualification, and operational qualification protocol plans and reports critical to product development.
  • Supports senior engineers by providing technical input for early development programs and supports the Quality Assurance team with any non-conformance investigations.

Who you are:
  • Bachelor's degree in chemical engineering, mechanical engineering, biomedical engineering, or related discipline.
  • One (1) to two (2) years of industry-related polymer processing experience in a manufacturing or product development environment
  • Ability to learn manufacturing process development, qualifications, and capability assessments.
  • Familiar with ISO 9001, and 13485 Quality Management Standards; knowledge of FDA Regulations
  • Ability to understand the client's needs, how the needs relate to project scopes, and how changes will affect other systems.
  • Ability to translate client inputs into engineering requirements based on technical skill set.
  • Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
  • Excellent analytical, critical thinking, and problem-solving skills.
  • Excellent organization and decision-making skills.
  • Experience in technical writing and use of statistical tools, including Minitab.
  • Proficient with MS Excel, MS Word, MS Project, and MS PowerPoint.

Perks / Benefits:
  • Generous Paid Time Off
  • Paid Breaks
  • Annual Bonuses
  • 401k with excellent company match
  • Health Insurance with multiple plans to choose from
  • Paid Short Term and Long Term Disability

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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