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Validation Engineer Biomedical Jobs in California

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 ...

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 ...

Valspec

Process Validation Engineer

Oceanside, CA

$70 - $80/hr

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... Required Qualifications * BS in Chemical, Biochemical, Mechanical, or Biomedical Engineering, or a ...

Ampa, Inc.

Sr. Prototype Engineer

San Diego, CA · On-site

$75K - $90K/yr

Prior experience as a mechanical test engineer, hardware test engineer, biomedical prototype engineer, R&D lab engineer, or similar hands-on hardware testing/validation role. Why Join Ampa? * Impact:

Block Imaging, Inc

Biomedical Site Manager

Sacramento, CA · On-site

$90K - $120K/yr

As a Biomedical Site Manager in the Biomedical Engineering Department, you lead with expertise and ... Maintain a valid driver's license and a driving record compliant with Block Imaging's driving ...

ADDSOURCE

Staff Reliability Engineer Hardware

San Jose, CA · On-site

$120K - $151K/yr

Required Skills Minimum 6+ years of experience in Reliability Engineering or Product Validation. Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical ...

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Validation Engineer Biomedical information

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 California? For Validation Engineer Biomedical jobs in California, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Biomedical jobs in California look for? The top searched job categories for Validation Engineer Biomedical jobs in California are:
What cities in California are hiring for Validation Engineer Biomedical jobs? Cities in California with the most Validation Engineer Biomedical job openings:
Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in California as of August 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 100% In-person job distribution.

Validation Engineer II

Alphatec Spine

Carlsbad, CA • On-site

Full-time

Re-posted 26 days ago

Job description

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing software verification activities, and contributing to continuous improvement and validation processes. The Validation Engineer II operates under limited supervision and collaborates closely with R&D, Software Engineering, Quality Engineering, Mechanical Engineering, Marketing, and Regulatory to deliver innovative products to market in accordance with FDA, ISO, and IEC standards.
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 a cloud-based end-to-end platform, among others.
The ideal candidate has experience validating software-based medical devices as well as strong technical, troubleshooting, documentation, and communication skills, and the ability to work seamlessly with cross-functional teams.
Essential Duties and Responsibilities
  • Leads verification and validation activities for assigned projects, ensuring quality, timeline, and compliance expectations are met while working alongside cross-functional teams.
  • Defines verification strategies for new product development, authoring high-quality test plans and protocols.
  • Supports continuous improvement of V&V practices by identifying inefficiencies, implementing process improvements, and participating in cross-functional problem-solving.
  • Creates and reviews design control documentation, ensuring requirements, test plans and protocols, test reports, and traceability meet FDA and internal quality standards.
  • Designs, develops, and qualifies manual and automated system-level test methods.
  • Performs validation of non-medical-device software tools and supporting systems as required, ensuring appropriate rigor and documentation.
  • Supports risk management activities in accordance with ISO 14971 by contributing to hazard analysis, risk controls, and verification of risk mitigations.
  • Seeks guidance from and collaborates with senior validation engineers; may informally assist with onboarding or knowledge sharing for newer team members.
  • Maintains regular and consistent attendance at the primary worksite.
  • Other duties as assigned.

Requirements
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Foundational understanding of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
  • Foundational understanding of IEC 62304 and IEC 60601 standards
  • Foundational understanding of ISO 14971 risk management requirements
  • Familiarity with defect tracking and test management tools (e.g., Jira, Polarion)
  • Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) and competency using desktop lab equipment (function generators, oscilloscopes, etc.)
  • Basic to working knowledge of probability and statistics concepts, and design of experiments (DoE)
  • Experience supporting Design History File (DHF) documentation and Change Order routing
  • Exposure to or experience supporting regulatory submissions such as 510(k)s
  • Demonstrated organizational and time-management skills to support cross-functional project activities
  • Ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members
  • Detail-oriented, deadline-driven, and able to work collaboratively in a team environment

Education and Experience
  • Bachelor's or master's degree in biomedical engineering or related field
  • 2-8 years of experience in V&V or systems engineering for medical devices, or other regulated industries

CERTIFICATES, LICENSES, REGISTRATIONS
ASQ CSQE or CQE preferred.
Equal Employment Opportunity & Other Disclosures
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.
Salary Range
Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $90,000 to $110,000 Full-Time Annual Salary
Please Note: The employer will not sponsor applicants for work visas for this position.

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