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Validation Engineer Biomedical Jobs (NOW HIRING)

Lonza

Validation Engineer

Houston, TX · On-site

Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline. * Minimum of 3-5 years of experience in validation within the biopharmaceutical ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering. * Six Sigma certification. * 3 years of validation experience in a cGMP Device ...

Barry-Wehmiller

Validation Engineer

Fort Worth, TX · On-site

Validation Engineer (Design Group) Who You'll Work With You will join one of our 45 offices in the ... Bachelor's degree in Bioengineering, Biomedical Engineering, Chemical Engineering, or similar ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Cybercoders

Biomedical Engineer

Emeryville, CA · Hybrid

Biomedical Engineer Biomedical Engineer - Medical Device Development (Catheter Systems) Location ... This role will drive R&D activities from concept through prototyping, verification and validation ...

Medline

Validation Engineer

Hartland, WI

$73K - $110K/yr

Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering. * Six Sigma certification. * 3 years of validation experience in a cGMP Device ...

Valspec

Process Validation Engineer

San Diego, CA

$75 - $85/hr

Required Qualifications * BS in Chemical, Biochemical, or Biomedical Engineering, Biology, Biochemistry, or a related technical field. * 8+ years of process validation experience in a pharmaceutical ...

Smith & Nephew

Software Validation Engineer 2

Austin, TX · On-site

$70K - $105K/yr

Mechanical, Chemical or Biomedical Engineering degree preferred with minimum 2 years of experience either in a pharmaceutical or orthopedic environment, performing routine validation and testing ...

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Validation Engineer Biomedical information

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How much do validation engineer biomedical jobs pay per hour?

As of Jul 15, 2026, the average hourly pay for validation engineer biomedical 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 the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are some typical challenges faced by Validation Engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What are the key skills and qualifications needed to thrive as a Validation Engineer in Biomedical, and why are they important?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What does a Validation Engineer do in the biomedical field?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.
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What cities are hiring for Validation Engineer Biomedical jobs? Cities with the most Validation Engineer Biomedical job openings:
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Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in the United States as of July 2026, with employment types broken down into 2% Internship, 1% As Needed, 83% Full Time, 13% Part Time, and 1% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Principal Engineer, Design Validation

Principal Engineer, Design Validation

Stryker

Fort Lauderdale, FL • On-site

$135K - $225K/yr

Full-time

Posted 14 days ago

Job description

Work Flexibility: Hybrid
What You Will Do:
We are currently seeking a Principal Design Validation Engineer to join our team in Weston, FL. This is a senior technical leader responsible for defining and scaling design validation strategy for complex medical devices and systems. In this role you will develop new design validation strategies for advanced navigation and surgical robotics programs, shape validation methodology across product portfolios, and drive cross-functional alignment on user needs, requirements traceability, design controls, and evidence generation needed to support safe, effective, and compliant product development and successful regulatory submissions. Your work will directly contribute to bringing new products to market that meet clinical needs and uphold the highest standards of quality and performance.
As a Principal Design Validation Engineer, you will apply core engineering principles across multiple disciplines to drive design validation activities. You will play a critical role in translating high level VOCs to User Needs, developing clinically relevant validation strategies, executing validation studies in different simulated use environments, ensuring that our products meet technical specifications and latest regulatory requirements. This role offers the opportunity to work on a global team in a dynamic, collaborative environment that values innovation, precision, and a commitment to improving patient outcomes.
Technical Responsibilities:
  • Lead enterprise-level or multi-program design validation strategy, including validation planning, execution frameworks, statistical rationale, acceptance criteria, and final design validation conclusions for complex hardware, software, and systems-based medical devices.
  • Drive development of robust user needs, intended use validation approaches, and end-to-end validation frameworks in partnership with Systems Engineering, R&D, Clinical, Regulatory, Quality, Marketing, and Human Factors teams.
  • Define and oversee advanced design validation methods that are objective, clinically relevant, risk-based, and statistically justified for intended users, use environments and surgical workflows.
  • Provide technical leadership for complex validation efforts involving cutting-edge navigation and robotics-assisted orthopedic systems and apply in-depth knowledge of the operating room environment to inform test method development, data interpretation and evaluate product performance.
  • Provide leadership in setting direction for meeting US AND EU's latest regulatory requirements for quantitative clinical accuracy design validation methods.
  • Lead the integration of diverse medical subsystems into cohesive, customer-ready solutions, optimizing interoperability, workflow efficiency, and overall system performance.
  • Mentor and influence in creation and correction of complex design validation test methodologies for product design issues.
  • Possesses an in-depth knowledge of the industry and competitive landscape. Partner in generating innovative insights and developing frameworks to prevent field issues by discovering business needs and validating them before product launch.

What You Will Need:
Required Qualifications:
  • Bachelor of Science in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Human Factor Engineering or related Lifesciences discipline.
  • Minimum 8+ years of work experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations

Preferred Qualifications:
  • Experience in Customer-centric Design, User Needs Research, Accuracy Testing and working through different stages of med tech development.
  • Strong understanding of Systems Engineering principles, relevant medical device regulations and standards such as FDA Guidance documents, IEC 62366, 60601-1-6, ANSI HE75.
  • Demonstrates mastery in technical writing for complex engineering documentation, including reports, protocols, procedures, and design specifications. Capable of establishing documentation standards, mentoring others in technical writing, and ensuring clarity and regulatory compliance across all deliverables.
  • Apply deep understanding of statistical methodologies to guide design validation and integration. Partner with cross-functional teams to interpret data and ensure adherence to design controls and regulatory expectations throughout new product development.
  • Exhibit proactive leadership, champion continuous improvement, foster innovation and mentor others in analytical and systematic thinking to achieve high-quality, compliant engineering outcomes.

  • $135,600 - $225,900 USD Annual

Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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