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Validation Engineer Medical Devices Jobs (NOW HIRING)

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 ...

eZone Staffing LLC

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Senior Service Engineer - Medical Devices

Mahwah, NJ · On-site

Senior Service Engineer - Medical Devices Location: New Jersey, USA Employment Type: Full-Time ... Valid driver's license and ability to travel to customer locations as required. * Ability to work ...

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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.

Senior Quality Engineer - Medical Devices

Stark Pharma Solutions Inc

Arden Hills, MN • On-site

$92K - $125K/yr

Contractor

Re-posted yesterday

Job description

Job Title: Senior Quality Engineer – Medical Devices

Location: Arden Hills, MN - Onsite

Job Summary:

We are seeking a Senior Quality Engineer with strong experience in combination products, particularly drug-coated medical devices. This role focuses on enhancing manufacturing processes, ensuring product quality, and maintaining compliance with regulatory standards.

The ideal candidate will bring deep expertise in quality systems, process validation, and regulatory compliance, along with hands-on experience supporting products from development through commercialization.

Key Responsibilities

  • Review and approve change requests related to product, process, validation, and verification documentation
  • Develop and maintain quality documentation including SOPs, quality plans, and inspection procedures
  • Ensure compliance with FDA, ISO, and regulatory requirements, including 21 CFR Part 211 and/or Part 4
  • Represent Quality in design reviews and cross-functional project discussions
  • Perform gap analyses and ensure alignment of product requirements and verification documentation
  • Review and approve validation activities including:
    • Process Qualifications (IQ/OQ/PQ)
    • Test Method Validations
    • Gage R&R and Process Capability Studies
    • Design of Experiments (DOE) and FMEAs
  • Support CAPA, NCR, and complaint investigations, including root cause analysis and effectiveness checks
  • Lead and support inspection and acceptance activities (FAI, in-process inspections, sampling plans)
  • Apply statistical tools and methodologies (SPC, DOE, ANOVA) to drive quality improvements
  • Collaborate with cross-functional teams to resolve quality issues and improve processes

Required Qualifications

  • Bachelor’s degree in Engineering or related field
  • 6–8+ years of experience in Quality or Design Quality Engineering within medical devices
  • Hands-on experience with combination products (drug-coated devices strongly preferred)
  • Strong knowledge of 21 CFR Part 211 and/or Part 4
  • Experience with process validation (IQ/OQ/PQ) and quality tools (SPC, DOE, FMEA, GR&R, CAPA)
  • Solid understanding of FDA regulations and ISO standards (ISO 13485, 14971, 11607)
  • Experience with CAPA ownership and quality event systems (e.g., NCEP)
  • Strong analytical, problem-solving, and communication skills