Understanding of medical device regulations, including ISO 13485, FDA 21 CFR Part 820 (for design ... testing. * Strong problem-solving and analytical skills, with a hands-on approach to product ...
Understanding of medical device regulations, including ISO 13485, FDA 21 CFR Part 820 (for design ... testing. * Strong problem-solving and analytical skills, with a hands-on approach to product ...
Senior R&D Engineer, Advanced Development - Pleasanton, CA
Pleasanton, CA · On-site
$140K - $160K/yr
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Lead the design, development, and testing of of critical electromechanical and fluidics systems and ...
Senior R&D Engineer, Advanced Development - Pleasanton, CA
Pleasanton, CA · On-site
$140K - $160K/yr
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Lead the design, development, and testing of of critical electromechanical and fluidics systems and ...
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Lead the design, development, and testing of of critical electromechanical and fluidics systems and ...
Quick apply
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Lead the design, development, and testing of of critical electromechanical and fluidics systems and ...
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Drive architectural trade studies using bench testing, prototyping, and simulation to validate ...
Quick apply
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Drive architectural trade studies using bench testing, prototyping, and simulation to validate ...
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Drive architectural trade studies using bench testing, prototyping, and simulation to validate ...
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Drive architectural trade studies using bench testing, prototyping, and simulation to validate ...
Clinical Research Engineer
Pleasanton, CA · Hybrid
Contribute to the design, development, and testing of firmware components and embedded systems used within Noctrix medical devices * Support device characterization, use-case testing, performance ...
New
Clinical Research Engineer
Pleasanton, CA · Hybrid
Contribute to the design, development, and testing of firmware components and embedded systems used within Noctrix medical devices * Support device characterization, use-case testing, performance ...
New
Clinical Research Engineer
Pleasanton, CA · On-site
Contribute to the design, development, and testing of firmware components and embedded systems used within Noctrix medical devices * Support device characterization, use-case testing, performance ...
New
Clinical Research Engineer
Pleasanton, CA · On-site
Contribute to the design, development, and testing of firmware components and embedded systems used within Noctrix medical devices * Support device characterization, use-case testing, performance ...
New
Test Engineer
Pleasanton, CA · On-site
Comply with regulatory requirements and documentation standards for Medical Device IT systems (e.g ... API Testing: RESTful API automation experience. * BDD Frameworks: Expertise in Cucumber . * CI/CD:
Quick apply
Test Engineer
Pleasanton, CA · On-site
Comply with regulatory requirements and documentation standards for Medical Device IT systems (e.g ... API Testing: RESTful API automation experience. * BDD Frameworks: Expertise in Cucumber . * CI/CD:
... medical device clinical engineering-related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc). * Strong background in hypothesis development and ...
Quick apply
... medical device clinical engineering-related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc). * Strong background in hypothesis development and ...
... medical device clinical engineering-related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc). * Strong background in hypothesis development and ...
... medical device clinical engineering-related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc). * Strong background in hypothesis development and ...
Staff Systems Engineer - Pleasanton, CA
$195K - $205K/yr
... testing, and proactively derisk critical technical challenges. This role carries direct ... The ideal candidate combines hands-on medical device experience , strong systems thinking , and the ...
Staff Systems Engineer - Pleasanton, CA
$195K - $205K/yr
... testing, and proactively derisk critical technical challenges. This role carries direct ... The ideal candidate combines hands-on medical device experience , strong systems thinking , and the ...
Contribute to design and implementation of automated testing and continuous integration processes * Ensure medical device software complies with applicable regulatory standards and that development ...
Quick apply
Contribute to design and implementation of automated testing and continuous integration processes * Ensure medical device software complies with applicable regulatory standards and that development ...
Contribute to design and implementation of automated testing and continuous integration processes * Ensure medical device software complies with applicable regulatory standards and that development ...
Contribute to design and implementation of automated testing and continuous integration processes * Ensure medical device software complies with applicable regulatory standards and that development ...
Sr. Electrical Engineer, Connected Systems & Combination Product Development, R&D
Pleasanton, CA · On-site
$124K/yr
Drive evaluation and application of connected medical device technologies that improve usability ... and testing workflows. Cross-Functional Collaboration * Collaborate with clinical, regulatory ...
Sr. Electrical Engineer, Connected Systems & Combination Product Development, R&D
Pleasanton, CA · On-site
$124K/yr
Drive evaluation and application of connected medical device technologies that improve usability ... and testing workflows. Cross-Functional Collaboration * Collaborate with clinical, regulatory ...
Drive evaluation and application of connected medical device technologies that improve usability ... and testing workflows. Cross-Functional Collaboration * Collaborate with clinical, regulatory ...
Quick apply
Drive evaluation and application of connected medical device technologies that improve usability ... and testing workflows. Cross-Functional Collaboration * Collaborate with clinical, regulatory ...
Sr. Electrical Engineer, Connected Systems & Combination Product Development, R&D
Pleasanton, CA · On-site
Drive evaluation and application of connected medical device technologies that improve usability ... and testing workflows. Cross-Functional Collaboration * Collaborate with clinical, regulatory ...
Sr. Electrical Engineer, Connected Systems & Combination Product Development, R&D
Pleasanton, CA · On-site
Drive evaluation and application of connected medical device technologies that improve usability ... and testing workflows. Cross-Functional Collaboration * Collaborate with clinical, regulatory ...
Clinical Development Engineer - Pleasanton, CA
$120K - $140K/yr
... medical device clinical engineering-related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc). * Strong background in hypothesis development and ...
Clinical Development Engineer - Pleasanton, CA
$120K - $140K/yr
... medical device clinical engineering-related activities strongly preferred (participating in conducting animal studies, in-vitro testing, etc). * Strong background in hypothesis development and ...
Contribute to design and implementation of automated testing and continuous integration processes * Ensure medical device software complies with applicable regulatory standards and that development ...
Contribute to design and implementation of automated testing and continuous integration processes * Ensure medical device software complies with applicable regulatory standards and that development ...
Sr. Engineer, R&D - Pleasanton, CA
Pleasanton, CA · On-site
$120K - $135K/yr
Strong engineering fundamentals and minimally invasive medical device design * Prototyping and testing experience (CNC, 3D printing) * Knowledge of FDA and ISO 13485 * Strong problem-solving and ...
Sr. Engineer, R&D - Pleasanton, CA
Pleasanton, CA · On-site
$120K - $135K/yr
Strong engineering fundamentals and minimally invasive medical device design * Prototyping and testing experience (CNC, 3D printing) * Knowledge of FDA and ISO 13485 * Strong problem-solving and ...
Sr. Engineer, R&D - Pleasanton, CA
$120K - $135K/yr
Strong engineering fundamentals and minimally invasive medical device design * Prototyping and testing experience (CNC, 3D printing) * Knowledge of FDA and ISO 13485 * Strong problem-solving and ...
Sr. Engineer, R&D - Pleasanton, CA
$120K - $135K/yr
Strong engineering fundamentals and minimally invasive medical device design * Prototyping and testing experience (CNC, 3D printing) * Knowledge of FDA and ISO 13485 * Strong problem-solving and ...
Medical Device Testing information
See Tracy, CA salary details
$25.58 is the 25th percentile. Wages below this are outliers.
$23.03 - $27.85
47% of jobs
The median wage is $29.19 / hr.
$27.85 - $32.68
9% of jobs
$32.68 - $37.50
0% of jobs
$37.50 - $42.32
4% of jobs
$46.31 is the 75th percentile. Wages above this are outliers.
$42.32 - $47.14
17% of jobs
$47.14 - $51.97
8% of jobs
$51.97 - $56.79
7% of jobs
$56.79 - $61.61
4% of jobs
$61.61 - $66.43
0% of jobs
$66.43 - $71.26
0% of jobs
$71.26 - $76.08
2% of jobs
$23
$39
$76
How much do medical device testing jobs pay per hour?
What are the key skills and qualifications needed for medical device testing?
To thrive in Medical Device Testing, you need a strong background in biomedical engineering, quality assurance, and regulatory compliance, often supported by a relevant degree. Hands-on experience with testing equipment, validation protocols, and familiarity with standards such as ISO 13485 and FDA guidelines are typically required. Attention to detail, analytical thinking, and clear documentation skills are essential soft skills for excelling in this field. These abilities ensure that devices meet safety and performance standards, protecting patient health and supporting company compliance.
What does medical device testing involve?
Professionals in Medical Device Testing typically spend their days conducting tests on new or existing medical devices to ensure they meet quality, safety, and regulatory standards. This often involves following strict protocols, documenting results accurately, and troubleshooting any performance or compliance issues that arise. Team members frequently collaborate with engineers, regulatory specialists, and manufacturing staff to ensure seamless product development and problem resolution. There may also be tasks related to preparing reports for regulatory submissions or participating in audits. This role offers the opportunity to make a real impact on patient safety while working in a collaborative, fast-paced environment.
What is medical device testing?
A Medical Device Testing job involves evaluating medical devices to ensure they meet regulatory standards, safety guidelines, and performance requirements. Professionals in this role conduct tests, analyze data, and document results to verify compliance with industry regulations such as FDA, ISO, and IEC standards. They work with engineers and regulatory teams to identify design flaws, improve product safety, and ensure reliability before market release. This job is crucial for preventing defects that could impact patient health and safety.
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The top searched job categories for Medical Device Testing jobs in Tracy, CA are:
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$140K - $160K/yr
Full-time
Medical, Retirement, PTO
Re-posted 6 days ago
Job description
Summary:
The Advanced Development team is responsible for early stage development and risk retirement of high risk and high reward design concepts. This team will develop proven ideas that work into the product development pipeline.
In This Role, You Will:
- Invent and evaluate early stage concepts. You will be asked to push limits and come up with creative and ground breaking solutions
- Lead the design, development, and testing of of critical electromechanical and fluidics systems and subsystems for an innovative kidney stone treatment device.
- Drive early phase product design concept ensuring manufacturability, reliability, scalability, and cost-effectiveness.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory, Clinical, and Marketing) to create solutions that best meets user needs.
- Develop test methods, create specifications, and execute early phase feasibility testing, including writing reports and documentation.
- Ensure compliance with FDA regulatory standards, maintaining adherence to the design control process throughout the product development lifecycle.
- Use SolidWorks to perform engineering calculations, create detailed models, and optimize product designs for manufacturing.
- Communicate project status, risks, and milestones effectively across all relevant departments.
- Collaborate with suppliers and internal teams to ensure product quality and seamless production.
Who You Will Report To:
- Vice President, Advanced Development
Requirements:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field and a minimum of 6 years of medical device experience, OR
- Master's degree in a related field and a minimum of 5 years of medical device experience, OR
- PhD in a related field and a minimum of 3 years of medical device experience.
- Experience with early concept and design development of innovative medical devices, including brainstorming, feasibility assessments, and prototyping.
- Understanding of medical device regulations, including ISO 13485, FDA 21 CFR Part 820 (for design controls and quality management), as well as best practices for mechanical design validation and risk management.
- Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance analysis, and cost optimization.
- Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
- Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.
- Strong problem-solving and analytical skills, with a hands-on approach to product development and testing
- Demonstrated ability to innovate and create solutions with incomplete or ambiguous requirements
- Work location: Pleasanton, CA
- Travel: less than 10%
- Full time employment
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
 What We Offer:
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.Â
We also offer an attractive compensation package, which includes:
- A competitive base salary range of $140,000 - $160,000 and variable incentive plan
- Stock options - ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k), healthcare insurance and paid vacation
About Calyxo
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
11 - 50 Employees
Headquarters location
Pleasanton, CA, US
Year founded
2016