Iso 13485 jobs in brea, ca

Irvine, California

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Today

Job Title: Component Engineer Location: Irvine, CA (Onsite) Duration- 12+ months Responsibilities: DVT & Design Release Support Participate in DVT readiness and design reviews to identify component risks, manufacturability concerns, and documentation gaps. Support design transfer activities to ensure readiness for manufacturing release. Component Risk & Lifecycle Assessment Evaluate lifecycle status (NRND/EOL), supplier risk, and availability Recommend alternates and mitigation strategies. Supp

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Contract

Depends on Experience

Engineer III

Irvine, California

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3d ago

Responsibilities: Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals. Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements. Define, develop, and validate/transfer test methods. Create verification plans, protocols, records, and reports. Support inv

Full-time

Engineer II, Risk Management & Post Market Quality

Irvine, California

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3d ago

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering tec

Full-time

USD 87,000.00 - 123,000.00 per year

Engineering Program Manager - Santa Ana, CA

Santa Ana, California

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3d ago

We anticipate the application window for this opening will close on - 15 Jun 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned. Develops and maintains Quality functional strategies, plans and schedules to

Full-time

USD 142,400.00 - 213,600.00 per year

Senior Engineer, Supplier Quality

Irvine, California

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3d ago

We are the people who give possibilities purpose 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. Job Description Job Responsibilities: Be a trus

Full-time

USD 105,500.00 - 168,800.00 per year

Software Quality Engineer II

Irvine, California

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3d ago

Job Description Job Summary The Software Quality Engineer II supports the development and lifecycle management of software used in medical devices by ensuring quality, compliance, and effective risk management throughout the product lifecycle. This role partners closely with Software Engineering, Systems Engineering, Regulatory Affairs, and Product Development teams to provide quality oversight from concept through commercialization. The Software Quality Engineer II is responsible for reviewi

Full-time

USD 75,000.00 - 100,000.00 per year

Complaint Evaluation Engineer

Rancho Santa Margarita, California

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3d ago

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than i

Full-time

USD 72,000.00 per year

Sr. Software Quality Engineer

Irvine, California

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3d ago

Full-time

USD 105,500.00 - 168,800.00 per year

Cybersecurity Quality Engineer

Irvine, California

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3d ago

Job Description Job Summary: The Cybersecurity Quality Engineer supports the integration of cybersecurity requirements into the product development lifecycle and quality management system for Masimo medical device products. Working under the guidance of senior quality, software, and cybersecurity team members, this role assists in ensuring cybersecurity-related activities are documented, traceable, and executed in accordance with applicable regulatory requirements, quality system procedures, a

Full-time

USD 85,000.00 - 105,000.00 per year

Senior Electrical Engineer

Irvine, California

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3d ago

Additional Location(s): US-CA-Irvine 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 - what

Full-time

USD 89,200.00 - 169,500.00 per year

Process Development Engineer

Hawthorne, California

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3d ago

SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologies to make this possible, with the ultimate goal of enabling human life on Mars. PROCESS DEVELOPMENT ENGINEER - BUILD RELIABILITY The Process Development Engineer is responsible for developing and improving business processes and systems that enable SpaceX to design, build, launch, and reuse the m

Full-time

USD 100,000.00 - 115,000.00 per year

Engineer II, Biocompatibility

Remote

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3d ago

Job Description Position Summary We are seeking a Biocompatibility Engineer II to join our team. As a member of the biocompatibility team, you will help ensure patient safety by contributing to the biological and toxicological evaluations of medical devices, materials, and processes. You will work closely with cross-functional teams to comply with global regulatory standards such as ISO 10993. You will leverage your understanding of the medical device biocompatibility field to provide guidance

Full-time

Software Quality Engineering Lead

Remote or Santa Clara, California

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3d ago

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 187,000.00 - 207,000.00 per year

Medical Device V&V engineers

Remote or New Jersey

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3d ago

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

Hardware Engineer - Design Controls Remediation

Remote

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14d ago

Title: Hardware Engineer Design Controls Remediation Duration: 9 months (potential to extend to 2 years) Remote: may request travel to sites on occasion TIMEZONE REQUIREMENTS: must work EST hours 8-3 pm EST M-F Number of openings: 1 Onboarding Phase 1-user needs, product requirements, outputs Role Summary The Hardware Engineer will lead gap assessments and remediation for hardware-related Design Inputs, Design Outputs, V&V, and Risk Management elements, ensuring mechanical and electrical hardwar

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Contract

$68 - $78

Sr. Electrical Engineer, Component

Irvine, California

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3d ago

Full-time

USD 102,000.00 - 168,200.00 per year

Technical Support - Mammography Equipment

Remote

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3d ago

Position Overview The Spec I, Ntl Tech Support - MG position is intended to provide technical assistance, primarily by telephone and on-site visits, to personnel on all HCUS Mammography (MG) and Women's Health products. This is the first-level national technical support engineer position in the company. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cut

Full-time

USD 43.27 - 48.55 per hour

Senior Software Design Assurance (Sr Software Design Quality) Engineer

Remote

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3d ago

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 95,900.00 - 159,900.00 per year

Senior Account Manager- Medical Devices

Remote

•

Today

Req ID: 137305 Remote Position: Yes Region: Americas Country: USA Summary Celestica is dedicated to delivering end-to-end product lifecycle solutions to drive our customers' success. Our growing Advanced Technology Solutions (ATS) organization focuses on applying Celestica's advanced capabilities, knowledgeable people and innovative tools to enable companies in the medical device industry with highly complex, mission critical applications to improve their competitive advantage. We are current

Full-time

USD 123,000.00 - 163,000.00 per year

Principal Engineer, Customer Quality

Remote

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3d ago

Littelfuse (NASDAQ: LFUS) is a diversified industrial technology manufacturing company shaping solutions for the safe and efficient transfer of electrical energy. Headquartered in Chicago, Illinois, USA, we serve customers across industrial, transportation, and electronics markets worldwide. With approximately 16,000 employees we design and manufacture innovative technologies that support electrification, energy efficiency, and advanced automation. Our global reach is matched by a culture that e

Full-time

USD 123,100.00 - 190,780.00 per year

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Iso 13485 jobs in Brea, CA, USA