ISO 13485 jobs in Brea, CA

Irvine, California

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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

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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

Product Safety Engineer / Lab Setting / Irvine, CA

Irvine, California

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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

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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

Engineer, Quality Control

Irvine, California

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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

Sr Engineer II, Process

Irvine, California

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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

Sr Engineer, Electronics Sustaining

Irvine, California

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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

Senior Staff R&D Process Development Engineer

Irvine, California

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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

Manager, IT Quality Engineering (LIMS) - El Segundo, CA or Frederick, MD

El Segundo, California

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Today

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great l

Full-time

USD 123,930.00 - 160,380.00 per year

R&D Principal Engineer - Electrophysiology

Irvine, California

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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 117,000.00 - 201,250.00 per year

Engineer II, Product Assurance & Reliability

Irvine, California

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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

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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 QMS Process Engineer

Remote or New Jersey

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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

Staff Machine Learning Engineer, Robotics

Remote or Santa Clara, California

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Today

Full-time

USD 141,000.00 - 227,700.00 per year

Sr. Software Engineer

Remote or Salt Lake City, Utah

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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

Senior Supplier Engineer

Remote or Danvers, Massachusetts

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Today

Full-time

USD 91,000.00 - 147,200.00 per year

Senior IT Purchasing Specialist

Remote

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Today

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications-from minimally invasive surgery to robotics to 3D metal printing. Novanta is one global

Full-time

USD 72,000.00 - 130,000.00 per year

Clinical Imaging & Machine Learning (ML) Validation Specialist

Remote

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4d ago

Job Title: Clinical Imaging & Machine Learning (ML) Validation Specialist Location: Remote Duration: Long Term Experience: 8 Years Job Summary The Clinical Imaging & ML Validation Specialist is responsible for validating, evaluating, and clinically contextualizing machine learning models applied to medical imaging. This role bridges clinical imaging expertise (radiology, pathology, cardiology, etc.) with data science and regulatory rigor to ensure ML models are accurate, reliable, unbiased, and

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Contract

Depends on Experience

Sr Device Engineer I

Remote or Foster City, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 136,340.00 - 176,440.00 per year

Penetration Tester

Remote

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11d ago

Role: Penetration Tester Location: Remote ( Should be travel ready to customer location once in a while for some testing) Job Summary: We are seeking an experienced Penetration Tester with specialized knowledge in medical devices and FDA 510(k) compliance to support our cybersecurity efforts. The ideal candidate will have hands-on experience conducting Threat Modelling, Ethical hacking and vulnerability assessments in FDA-regulated environments, ensuring our connected medical products meet secur

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Third Party, Contract

Depends on Experience

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ISO 13485 jobs in Brea, CA, USA