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Validation Engineer Biomedical Jobs in Austin, TX

OriGen Biomedical

Sustaining Engineer I

Austin, TX · On-site

$91K - $112K/yr

COMPANY OriGen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We ... Consult with marketing and regulatory to identify new markets for devices and plan new validation ...

Zimmer, Inc.

Development Sr Engineer II

Austin, TX

... Biomedical Engineering or related engineering discipline with 3+ years of experience * Prior experience in medical device development required. * Strong experience with verification and validation ...

Enovis

Systems Engineer III

Austin, TX · On-site

Participate in verification and validation activities with V&V teams to ensure compliance with ... Engineering, Biomedical Engineering, or related field * 3+ years of experience in systems ...

Enovis

Software Engineer II

Austin, TX · On-site

Participate in verification and validation activities with V&V teams to ensure compliance with ... Engineering, Biomedical Engineering, or related field * 3+ years of experience in systems ...

Enovis

Systems Engineer III

Austin, TX

Participate in verification and validation activities with V&V teams to ensure compliance with ... Engineering, Biomedical Engineering, or related field * 3+ years of experience in systems ...

Enovis

Software Engineer II

Austin, TX · On-site

Participate in verification and validation activities with V&V teams to ensure compliance with ... Engineering, Biomedical Engineering, or related field * 3+ years of experience in systems ...

Enovis

Software Engineer II

Austin, TX · On-site

Participate in verification and validation activities with V&V teams to ensure compliance with ... Engineering, Biomedical Engineering, or related field * 3+ years of experience in systems ...

Enovis

Software Engineer II

Austin, TX · On-site

Participate in verification and validation activities with V&V teams to ensure compliance with ... Engineering, Biomedical Engineering, or related field * 3+ years of experience in systems ...

Enovis

Software Engineer II

Austin, TX

Participate in verification and validation activities with V&V teams to ensure compliance with ... Engineering, Biomedical Engineering, or related field * 3+ years of experience in systems ...

Pwc

Supply Chain Consulting - Relex Sr. Manager

Austin, TX · On-site

$124K - $280K/yr

... and validating outcomes with clients. In this role at PwC, you will focus on optimizing supply ... Aerospace Engineering, Automotive Engineering, Biomedical Engineering, Chemical Engineering ...

Tekhawks LLC

Be Seen First

Design Verification Engineer - Design Assurance

Austin, TX · On-site

$38 - $42/hr

Support software validation documentation, including protocol and report work, where applicable ... Technical background (Biomedical, Electrical, or broad Mechanical) sufficient to evaluate whether ...

Tekhawks LLC

Be Seen First

Design Verification Engineer - Design Assurance

Austin, TX · On-site

$38 - $42/hr

Support software validation documentation, including protocol and report work, where applicable ... Technical background (Biomedical, Electrical, or broad Mechanical) sufficient to evaluate whether ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Austin, TX

Validation Engineer Biomedical information

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$51

$77

How much do validation engineer biomedical jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for validation engineer biomedical in Austin, TX is $51.54, according to ZipRecruiter salary data. Most workers in this role earn between $39.09 and $62.64 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?

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 biomedical?

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.
What are popular job titles related to Validation Engineer Biomedical jobs in Austin, TX? For Validation Engineer Biomedical jobs in Austin, TX, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Biomedical jobs in Austin, TX look for? The top searched job categories for Validation Engineer Biomedical jobs in Austin, TX are:
What cities near Austin, TX are hiring for Validation Engineer Biomedical jobs? Cities near Austin, TX with the most Validation Engineer Biomedical job openings:
Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in Austin, TX as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 80% In-person, and 20% Hybrid job distribution, with an average salary of $107,202 per year, or $51.5 per hour.

Sustaining Engineer I

OriGen Biomedical

Austin, TX • On-site

$91K - $112K/yr

Full-time

Posted 9 days ago

Job description

COMPANY
OriGen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We collaborate with top
researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve
customer satisfaction by providing safe and effective products that positively impact the quality of life.
POSITION SUMMARY
The Sustaining Engineer level I will support on-market Class I and Class II disposable, sterile medical devices with
technical support, product training, improved processes, contingency planning, and implementation of cost savings
initiatives. The sustaining engineer will assist both manufacturing and development engineers to maintain our on-
market devices.
ESSENTIAL DUTIES AND RESPONSIBILITIES
  • The essential duties and responsibilities of this position include, but are not limited to the following:
  • Draft and execute test protocols to demonstrate product capabilities that meet customer needs.
  • Manage the design history files of on-market devices and keep to state-of-the-art standards.
  • Consult with marketing and regulatory to identify new markets for devices and plan new validation and testing activities as necessary.
  • Assess risk to the design, manufacturing process, and use of on-market devices.
  • Execute risk mitigation activities to reduce risk to patients as far as possible and document to current standards.
  • Assist in complaint and discrepant material investigations with good documentation and reporting.
  • Create supply-chain contingency plans for critical raw material components of on-market devices.
  • Assist Development Engineering with variant development projects of on-market devices including preparation of cost estimations, drawings, and samples.
  • Provide product technical support to account managers and customer service.
  • Train manufacturing technicians and quality inspectors to the use of products.
  • Establish and maintain standards for released drawings and material specifications.
  • Review revisions to Standard Operating Procedures and manufacturing instructions.
  • Evaluate and document process risks that tie into validation.
  • Perform Root Cause Analysis of product-related problems, plan, and implement corrective actions.
  • Other duties and/or projects as assigned
REQUIRED SKILLSETS
Knowledge of FDA regulations and GMP guidelines for medical device validation.
Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish
deadlines and objectives.
Proficiency in technical and layman writing.
Works in cross functional teams to complete projects and testing.
Knowledge of and skills in using computer software and hardware applications, including Microsoft Word,
CAD, and Excel.
Outstanding communication skills, both written and oral, and will be expected to communicate directly with
production management, production technicians, engineers, and senior management.
COMPETENCIES
  • Self-motivated
  • Broad creativity and curiosity
  • Problem-solving skills
  • Computer Aided Design software (e.g. SolidWorks)
  • Project Management
  • Ethical Conduct
  • Communication and interpersonal skills
  • Strategic Thought
  • Adaptability
  • DOE and Validation testing
  • Decision making
  • Corrective and preventative actions

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, amp; ABILITIES)
  • Bachelor’s degree in Engineering OR 4+ years’ experience in engineering principals of medical devices /ISO 13485 environment
  • Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
  • Strong interpersonal and people skills
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Strong and effective communication skills (verbal and written)
  • Close attention to detail
  • Ability to work independently and lead or participate in a cross-functional team environment
PREFERRED QUALIFICATIONS
  • ISO 13485 experience
SUPERVISORY RESPONSIBILITY
This position has no supervisory responsibilities. This position may be required to lead/report on projects and
ensure participants meet deadlines.
WORK ENVIRONMENT
This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur. This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.
  • Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required
PHYSICAL DEMANDS amp; WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully
perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to
enable individuals with disabilities to perform the functions.
While performing the duties of this position, the employee is regularly required to talk and hear. The employee is
frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently
required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift
and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet
jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision,
and the ability to adjust focus.

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