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Validation Engineer Biomedical Jobs (NOW HIRING)

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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$22

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$78

How much do validation engineer biomedical jobs pay per hour?

As of Jun 24, 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:
What states have the most Validation Engineer Biomedical jobs? States with the most job openings for Validation Engineer Biomedical jobs include:
What job categories do people searching Validation Engineer Biomedical jobs look for? The top searched job categories for Validation Engineer Biomedical jobs are:
Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in the United States as of June 2026, with employment types broken down into 88% Full Time, 3% Part Time, 1% Temporary, and 8% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Software Validation Engineer 2

Software Validation Engineer 2

Smith & Nephew

Austin, TX • On-site

$70K - $105K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 23 days ago

Smith & Nephew rating

8.2

Company rating: 8.2 out of 10

Based on 40 frontline employees who took The Breakroom Quiz

77th of 520 rated manufacturers

Job description

Software Validation Engineer 2
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Software Validation Engineer will lead and support software validations that are custom developed for S+N in house or by vendor, in addition to commercial off the shelf software applications, which may be directly used for patient care, or software used by S&N's manufacturing and quality systems.
This position is part of a team that may be actively involved in the product development lifecycle with regard to software validation activities, while also participating in product risk assessments, code and design reviews, and the development of software validation deliverables that are identified with in-group specifications.
This role does require the engineer to be effective at working independently under limited supervision and with other engineers and departments.
The Software Validation Engineer will also be responsible for following the specifications assigned to them via Training Management, whether it be in-person or electronic.
Additionally, the engineer will also be required to meet annual objectives and promote continuous improvement efforts as designated by management, while supporting and emulating S+N cultural pillars.
What will you be doing?
  • Collaborate with other groups (written and Teams meetings) in support of software validation projects
  • Collaborate with other groups (written and Teams meetings) in support of regulatory submissions as needed
  • Review and approve software validation documentation for both medical and non-medical device software
  • Produce software validation packages for both medical and non-medical device software
  • Review and approve supplier documentation as needed
  • Review and approve specifications as needed
  • Create, update, review and approve Quality Plans as needed
  • Update and maintain software validation specifications as needed
  • Adhere to applicable regulatory requirements from multiple countries
  • Support and drive non-conformance reporting and mitigation efforts as needed
  • Support and execute CAPA mitigation efforts as needed
  • Ensure assigned training is completed and up to date at all times
  • Demonstrate proficiency with in-group specifications

What will you need to be successful?
  • Bachelors degree required with a minimum 3 years of experience either in a pharmaceutical or orthopedic environment, performing routine validation and testing activities.
  • 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 activities.
  • Must be able to communicate effectively both verbally and in written form, build productive relationships, demonstrate effective project and time management, proficiency using PC Applications including but not limited to Microsoft Word, PowerPoint and Excel.
  • Working knowledge of C, C++, Python, MATLAB, SQL preferred
  • MCSE, ASQ yellow+, FE (EIT) certifications preferred

Physical Demands: Must be able to sit at a desk during normal business hours and work almost entirely on a computer while leveraging the necessary peripherals. Must be able to lift 25 lbs.
You.Unlimited.
  • Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  • Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
  • Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
  • Flexibility: Hybrid Work Model (For most professional roles)
  • Training: Hands-On, Team-Customized, Mentorship
  • Extra Perks: Discounts on fitness clubs, travel and more!

#LI
The anticipated base compensation range for this position is $70,500 - $105,750 USD annually (or hourly) The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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