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Validation Engineer Medical Devices Jobs (NOW HIRING)

Haumiller Engineering Co

Validation Engineer

Belvidere, IL · On-site

$73K - $95K/yr

Validation Engineer Haumiller Engineering is a 100% employee-owned company that designs and builds custom high-speed automation assembly machines for medical devices, consumer goods and industrial ...

Pinnaql

Validation Engineer - Upstream

Manati, PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and ...

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

As of Sep 4, 2026, the average hourly pay for validation engineer medical devices in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is a validation engineer medical devices?

A Validation Engineer in medical devices ensures that products, processes, and equipment meet regulatory and quality standards. They develop and execute validation protocols, conduct tests, analyze data, and document results to ensure compliance with FDA, ISO 13485, and other regulations. Their role is crucial in verifying that medical devices are safe, effective, and consistent in performance before they reach the market.

What are the key skills and qualifications needed to thrive as a validation engineer medical devices?

A Validation Engineer in Medical Devices needs a strong background in biomedical engineering or a related field, knowledge of regulatory requirements (such as FDA or ISO 13485), and expertise in validation methodologies. Familiarity with tools like statistical analysis software, quality management systems (QMS), and documentation platforms is often required, as well as certifications such as CQE (Certified Quality Engineer). Strong attention to detail, problem-solving abilities, and effective communication skills are essential to excel in this role. These competencies are critical to ensure medical devices meet rigorous safety and compliance standards, protecting patient health and supporting successful product launches.

What are some typical challenges faced by validation engineers in the medical device industry?

Validation Engineers in the medical device industry often encounter challenges such as navigating ever-evolving regulatory standards, managing tight project timelines, and ensuring thorough documentation for audits. They are frequently tasked with balancing the need for comprehensive testing and validation with efficiency to support product development cycles. Working closely with cross-functional teams—including design, quality assurance, and manufacturing—requires strong collaboration and adaptability. Overcoming these challenges helps ensure that medical devices are safe, effective, and compliant with industry regulations, making the role both demanding and highly impactful.

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Validation Engineer Medical Devices jobs near you
Infographic showing various Validation Engineer Medical Devices job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Validation Engineer

Validation & Engineering Group, Inc.

Holly Springs, NC • On-site

Full-time

Re-posted 22 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.

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