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Validation Engineer Biomedical Jobs in California

Masimo

Engineer II, Algorithm

Irvine, CA · On-site

$120K - $150K/yr

... validation, and product integration. * Apply statistical analysis, numerical modeling, machine learning, and digital signal processing techniques to solve complex biomedical engineering problems.

Masimo

Engineer II, Algorithm

Irvine, CA

$120K - $150K/yr

... validation, and product integration. * Apply statistical analysis, numerical modeling, machine learning, and digital signal processing techniques to solve complex biomedical engineering problems.

MiniMed

Principal Biomedical Engineer

Northridge, CA · On-site

This Principal Biomedical Engineer will partner cross functionally to highlight insights from real ... Familiarity with analytical method transfer and equipment/process validation in cGMP environments.

MiniMed

Principal Biomedical Engineer

Los Angeles, CA · On-site

This Principal Biomedical Engineer will partner cross functionally to highlight insights from real ... Familiarity with analytical method transfer and equipment/process validation in cGMP environments.

Masimo

Cybersecurity Quality Engineer

Irvine, CA · On-site

$85K - $105K/yr

... validation records within the Design History File (DHF). * Support authoring, review, and periodic ... Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical ...

Masimo

Cybersecurity Quality Engineer

Irvine, CA

$85K - $105K/yr

... validation records within the Design History File (DHF). * Support authoring, review, and periodic ... Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical ...

Sodexo

Biomedical Equipment Technician 3

Chula Vista, CA · On-site

$42.37 - $55.53/hr

A valid driver's license and acceptable driver's license record check is required.**** What You'll ... engineering or a discipline geared toward managing maintaining and repairing clinical equipment ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in California

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, 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.
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 July 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 100% In-person job distribution.
Sr. R&D Engineer, New Products

Sr. R&D Engineer, New Products

Align Technology

San Jose, CA • On-site

$136K - $188K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 9 days ago

Job description

Sr. R&D Engineer, New Products
Department: Research & Development
Employment Type: Full Time
Location: US-California-San Jose
Compensation: $136,700 - $188,000 / year
Description
We are seeking a Sr. R&D Engineer, New Products to lead the research, design, development, and launch of innovative medical devices from concept through commercialization. In this role, you will partner closely with cross-functional teams across R&D, Product Management, Clinical, Quality, Regulatory, and Operations to identify unmet needs, evaluate new technologies, develop and test prototypes, and translate insights into robust product solutions. This is a hands-on engineering role for someone who thrives in fast-paced product development environments and enjoys solving complex technical challenges from early feasibility through product launch and post-launch improvement.
Role expectations
  • Lead product development workstreams from concept through launch, including planning, execution, and cross-functional coordination
  • Design, prototype, and evaluate product concepts using biomechanical models, benchtop methods, and experimental testing
  • Develop and execute verification and validation activities to assess product performance and design robustness
  • Design, build, and verify test hardware, fixtures, and systems, including automation tools, as needed to support product development
  • Apply sound mechanical and engineering principles to understand, model, and solve problems involving complex systems
  • Perform statistical analysis and interpret data to guide technical decisions and product improvements
  • Communicate technical findings, recommendations, and product insights effectively to stakeholders at all levels
  • Collaborate with cross-functional partners to incorporate design inputs, technical requirements, and user needs into product prototypes and final designs
  • Partner with Clinical Affairs and cross-functional teams to support clinical studies and other product investigations
  • Generate clear, complete technical documentation in compliance with FDA, ISO, and internal medical device development requirements, including protocols, reports, and design documentation
  • Contribute to invention generation, intellectual property development, and patent disclosures
  • Prioritize and execute work effectively in a fast-paced environment with evolving priorities and critical timelines
  • Provide broad engineering support as needed

What we're looking for
  • B.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 8+ years of experience in biomedical research and/or product development
  • M.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 6-7 years of experience in biomedical research and/or product development
  • Ph.D. in Mechanical Engineering, Biomedical Engineering, or a related field with 3-5 years of experience in biomedical research and/or product development
  • Higher or lower years of experience will be considered for this role, with job level and title adjusted accordingly
  • Strong theoretical and experimental background in structural mechanics and biomechanics
  • Experience with 3D CAD solid modeling and mesh-based modeling tools
  • Test method development, verification, and validation
  • Data analysis, scripting, and automation for experimental and design workflows
  • Additive manufacturing (3D printing) for test fixtures, prototypes, and end-use product applications
  • Experience in the medical device industry

Pay Transparency
If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate's pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.
For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.
Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.
General Description of All Benefits
We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.
Family Benefits. Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans. Align also offers to employees:
  • Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
  • Back-up Child/Elder Care and access to a caregiving concierge
  • Family Forming Benefits - Available to Employees, and their spouse or domestic partner, covered under one of Align's health plans
  • Breast Milk Delivery and Lactation Support Services
  • Employee Assistance Program
  • Hinge Health Virtual Physical Therapy - Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan

Employee benefits. Align offers its employees:
  • Short-term and long-term disability insurance in accordance with those plans.
  • Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
  • Flexible Spending Accounts- Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
  • 401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%.). Employer match vests after two years - 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
  • Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
  • Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days. Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
  • Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
  • 11 Company-designated paid holidays throughout the year.
  • If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave. All parental leave must be completed within one year of the birth or placement of the child. Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
  • Non-exempt employees will receive full pay for up to 10 days of jury duty. Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.

To the extent applicable state or local law offers more generous benefits, Align complies with any such law.

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