ISO 13485 jobs in CA

Pleasanton, California

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Yesterday

Key Responsibilities: Design and develop automation frameworks using TypeScript, JavaScript, Node.js.Implement UI automation using Playwright and Cypress.Build and maintain API automation solutions.Integrate automation suites with test management tools.Collaborate with developers and QA teams to ensure BDD practices using Cucumber.Set up and maintain CI/CD pipelines for automated test execution.Participate in code reviews and contribute to best practices for test automation.Troubleshoot and opti

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Third Party, Contract

$60 - $65

Senior Staff R&D Process Development Engineer

Irvine, California

•

Today

Work Flexibility: Onsite Stryker Inari is seeking a skilled R&D Development Engineer to support the scale-up and manufacturing readiness of an innovative electro-mechanical medical device integrating precision components and injection-molded parts. This role focuses on developing, optimizing, and validating robust manufacturing processes to ensure product quality, reliability, and regulatory compliance. This role is fully onsite role in Irvine, CA with the expectation to be in office 5 days a

Full-time

USD 115,600.00 - 190,400.00 per year

Senior Quality Engineer

Irvine, California

•

Today

Senior Medical Device Quality Engineer / Senior Sustaining Quality Engineer Needed for Growing Medical Device Company! This Jobot Job is hosted by: Reed Kellick Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $90,000 - $120,000 per year A bit about us: We are a growing medical device company that is on the lookout for a talented Senior Design Quality Engineer / Senior Supplier Quality Engineer! Why join us? As a Senior Product Quality Eng

Full-time

USD 90,000.00 - 120,000.00 per year

Product Certification Safety- EE Contractor

Lake Forest, California

•

Today

Location: Lake Forest, CA Salary: $50.00 USD Hourly - $75.00 USD Hourly Description: Minimum Qualifications Education: Bachelor's degree in Electrical Engineering or related field.Experience: 4+ years in medical device product safety compliance evaluations or experience in fully accredited test labs (e.g., UL, CSA, Intertek, Element).Expertise: Deep knowledge of IEC 60601-1 3rd Edition (including 3.1 and 3.2), collateral and particular standards for medical electrical equipment.Collaboration

Contract

USD 50.00 - 75.00 per hour

Project (Design) Mgr 3

Sunnyvale, California

•

Today

Position Summary: We are seeking a dynamic and experienced Software Project Manager to lead and coordinate the development of cutting-edge surgical robotic platforms. The successful candidate will be responsible for managing software development lifecycles, ensuring timely delivery, compliance with medical device standards, and collaboration across multidisciplinary teams including but not limited to: product management, software & controls engineers, hardware engineers, clinical design enginee

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Contract

$75

Product Safety Engineer / Lab Setting / Irvine, CA

Irvine, California

•

Today

Our client, based in South Orange County, is one of the leading medical device manufacturers in the optical surgery industry. They are urgently seeking a Laboratory Safety Engineer to work hands-on with their medical devices in the lab. The company continues to expand, adding new engineers to their teams each month. This role is hybrid with four days onsite per week, so candidates must be local to the South Orange County area. Required Qualifications Education & Experience: BS degree with 3+ y

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Full-time

USD 65.00 - 70.00 per hour

Medical Device Electrical Safety Engineer | Lake Forest, California | Onsite

Lake Forest, California

•

Today

Title: Medical Device Electrical Safety Engineer Location: Lake Forest, California | Onsite Duration: 6-12+ Months Role Requirements: Minimum Education and Experience: BS + 2 years in medical device products safety/EMC compliance, and/or fully-accredited test labs such as UL, CSA, Intertek or Element, etc. Proven experience in successfully being able to work cross functional teams EMC/60601-1 experience with Medical Devices is a MUST Core responsibilities: Perform Safety, EMC and Wireless tes

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Contract, Third Party

Sr. Software Engineer

Remote or Salt Lake City, Utah

•

Today

Sr. Software Engineer (onsite or remote depending on location) Salt Lake City, UT or Denver, CO Direct Hire Pay: $140k-$160k Job Description: Our client is looking for a Sr. Software Engineer. As part of the team working in R&D, you will work across multiple languages and frameworks, including React Native, React, TypeScript, JavaScript, Python, and AWS (Flutter is a plus). You'll operate within a regulated SDLC (FDA, 62304/82304) emphasizing automation, testing, observability, cybersecurity,

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Full-time

USD 140,000.00 - 160,000.00 per year

Staff Machine Learning Engineer, Robotics

Remote or Santa Clara, California

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 141,000.00 - 227,700.00 per year

Senior Supplier Engineer

Remote or Danvers, Massachusetts

•

Today

Full-time

USD 91,000.00 - 147,200.00 per year

Senior QMS Process Engineer

Remote or New Jersey

•

Today

Responsibilities: Draft, update, and optimize QMS procedures to align with Code beamer upgrades, organizational standards, and regulatory requirements. Collaborate with cross-functional Quality and R&D teams to ensure procedures accurately reflect best practices and compliance expectations. Translate technical and regulatory requirements into clear, practical documentation for end users. Support change management processes, ensuring procedural updates are properly controlled and communicated. En

Full-time

Sr Engineer, Electronics Sustaining

Irvine, California

•

Today

Job Description Job Summary: The Sr Engineer, Electronic Sustaining is a highly skilled technical contributor responsible for ensuring the long-term performance, reliability, manufacturability, and lifecycle continuity of Masimo's electronic circuit board assemblies. This role independently executes complex sustaining engineering activities across multiple product families, including advanced component obsolescence management, verification carrier design, deep-dive root-cause analysis, and cro

Full-time

USD 110,000.00 - 130,000.00 per year

Sr Engineer II, Process

Irvine, California

•

Today

Job Description Job Summary: The Sr. Engineer II, Process is responsible for developing, improving, and validating new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports new process development (NPI) and product transfers to worldwide manufacturing facilities, implements and supports/utilizes effective manufacturing methodologies, such as Lean manufacturing, DFM, visual Workshop, SPC, etc., always following local and international regula

Full-time

USD 120,000.00 - 155,000.00 per year

Engineer, Quality Control

Irvine, California

•

Today

Job Description Job Summary Responsible for providing technical leadership for all aspects of quality control program to ensure continuous production of products consistent with established standards. Monitors and analyzes statistical data and product specifications to determine conformance of incoming raw materials, subassemblies, and finished products to established company requirements and specifications, and applicable industry standards. Handles multiple projects from product inception an

Full-time

USD 69,000.00 - 91,000.00 per year

Principal R&D Engineer, Exploratory

Carlsbad, California

•

Today

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your

Full-time

USD 103,700.00 per year

R&D Principal Engineer - Electrophysiology

Irvine, California

•

Today

Full-time

USD 117,000.00 - 201,250.00 per year

Engineer II, Product Assurance & Reliability

Irvine, California

•

Today

Job Description Job Summary The Product Assurance and Reliability Engineer II position at Masimo is a multifaceted role that requires a good understanding of basic science as well as engineering. An individual in this role will be part of the Product Assurance department working to investigate, test, and provide expertise in the effort to improve the quality and reliability of Masimo's product portfolio. The role requires a person with experience in one or more of the following specific areas

Full-time

USD 85,000.00 - 100,000.00 per year

Staff Engineer

Brea, California

•

Today

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human e

Full-time

USD 124,700.00 - 205,800.00 per year

Senior Software Quality Assurance Engineer (SQE)

Pleasanton, California

•

Today

We are seeking a highly experienced and efficient Senior Software Quality Assurance (SQE) Engineer to join our Quality team. This critical role focuses on the validation and compliance of non-product, business-critical computerized systems in our regulated environment. The ideal candidate will have deep expertise in Computer System Validation (CSV) within design-controlled industries, ISO 9001 and ISO 13485 with a strong drive to automate all manual processes for increased effectiveness and reli

Full-time

USD 165,800.00 - 224,400.00 per year

Principal R&D Engineer

Carlsbad, California

•

Today

Full-time

USD 103,700.00 per year

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ISO 13485 jobs in California, USA