Iso 13485 jobs in lake forest, ca

Irvine, California

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Today

Biomedical / Electrical / Mechanical Engineer - Medical Device Quality Location: Irvine, CA Job Type: Contract with Health and 401k benefits Duration: 1 year Schedule: M - F, 8-5 Experience: 2+ years We are seeking an early-career Biomedical, Electrical, or Mechanical Engineer to support quality and technical investigations for medical devices. This is a hands-on opportunity for an engineer who enjoys troubleshooting products, investigating technical issues, documenting findings, and worki

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Contract

$35.27 - $40.82

Manufacturing Engineering Manager

Irvine, California

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Today

Lead Manufacturing Excellence in a Growing, FDA-Regulated EnvironmentA well-established and innovative medical technology manufacturer is seeking a Manufacturing Engineering Manager to lead a high-performing engineering team responsible for manufacturing processes, production equipment, New Product Introduction (NPI), and continuous improvement initiatives. This is a hands-on leadership opportunity for an engineering professional who enjoys developing people, driving operational excellence, and

Full-time

Compensation information provided in the description

New Product Development (NPD) Engineer

Irvine, California

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14d ago

Job Description: We are looking for an experienced NPD Engineer to support the development and design of electro-mechanical systems and components for medical device products. The ideal candidate will have strong experience in New Product Development, electro-mechanical design, automation, CAD, and medical device regulatory requirements. Responsibilities: Design and develop electro-mechanical systems, assemblies, and components for new products. Perform system integration of mechanical and elec

Full-time

Validation Engineer

Irvine, California

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14d ago

Job summary We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience with IQ/OQ/PQ, process andequipment validation, verification and validation (V&V), CAPA, root cause analysis,and process improvement. The candidate will collaborate with cross-functional teams and customers to ensure validation activities meet regulatory, quali

Full-time

Sr Test Engineering Technician

Irvine, California

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Today

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Masimo, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of

Full-time

USD 33.00 - 39.00 per hour

Engineer II, Mechanical - Sensors

Irvine, California

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Today

Full-time

USD 90,000.00 - 115,000.00 per year

Engineer II, Design Quality (Hybrid - San Clemente, CA)

San Clemente, California

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Today

Job Description Position Summary Provide quality support for ICU Medical Consumables development. The Quality Engineer will support activities such as CAPA investigations, Post Market Risk Assessments, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards. Essential Duties & Responsibilities Effectively utilize quality tools

Full-time

USD 71,250.00 - 102,125.00 per year

Engineer II, Process

Irvine, California

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Today

Full-time

USD 90,000.00 - 120,000.00 per year

Engineer II

Irvine, California

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14d ago

Job Description: We are seeking a Systems Engineer II to join a Device and Combination Product Development - R&D team. The engineer will contribute to the development and launch of innovative drug-device combination products. The role will integrate multiple engineering disciplines to support robust, safe, compliant, and patient-focused product design and performance. Responsibilities: Develop and maintain Design History Files (DHF) and Design Control documentation in compliance with applicable

Full-time

Engineer II, Mechanical - Sensors

Irvine, California

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22d ago

Job Description Job Summary: The Engineer II, Mechanical - Sensors is responsible for the design, development, testing, and sustaining of mechanical components and assemblies for patient monitoring sensors and related products. This position applies mechanical engineering principles to develop reliable, manufacturable solutions from concept through production and collaborates cross-functionally to support product performance, quality, regulatory, and manufacturing requirements. Please note th

Full-time

USD 90,000.00 - 115,000.00 per year

Engineer II, Process

Irvine, California

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22d ago

Job Description Job Summary: The Engineer II, Process supports the development, implementation, validation, and continuous improvement of manufacturing processes and equipment used to produce Masimo products. This role applies engineering principles and data-driven problem solving to improve process capability, quality, efficiency, and manufacturability while supporting new product introduction and sustaining manufacturing activities in compliance with applicable quality and regulatory require

Full-time

USD 90,000.00 - 115,000.00 per year

Engineer II, Algorithm

Irvine, California

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Today

Full-time

USD 110,000.00 - 135,000.00 per year

Engineer II, Software Automation

Irvine, California

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Today

Full-time

USD 80,000.00 - 105,000.00 per year

Engineer II, Software Automation

Irvine, California

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22d ago

Job Description Job Summary: The Engineer II, Software Automation is responsible for developing, executing, and maintaining scalable test automation frameworks and infrastructure for complex, distributed systems - including microservice-based software platforms, on-prem and cloud deployments, and the in-house and third-party devices they integrate with. This role is a key technical contributor within the Systems Test Engineering organization, developing automation solutions that improve test e

Full-time

USD 80,000.00 - 105,000.00 per year

VP, Process Engineering & Automation

Irvine, California

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22d ago

Job Description Job Summary: The VP, Process Engineering & Automation provides strategic organizational and technical leadership for Process Engineering, Manufacturing Test Engineering, and Automation across Masimo's global manufacturing network. This role establishes and executes the enterprise strategy for manufacturing processes, manufacturing test systems, automation, equipment, industrialization, and manufacturing technology to enable scalable production, operational excellence, product q

Full-time

USD 220,000.00 - 300,000.00 per year

Sr CAPA Engineer

Remote or Waltham, Massachusetts

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Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

Technical Project/Program Management - Technical Program Manager V

Remote

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Today

Job#: 3053591 Job Description: Technical Project/Program Management - Technical Program Manager V Compensation: $12- - $130 hourly Location: Remote, California (Remote) Role Overview We are seeking a senior Technical Program Manager with relevant Software as a Medical Device (SaMD) experience. This role focuses on managing the software release process for a key medical device feature. The position requires leading cross-functional teams to ensure deliverables are completed in accordance wit

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Full-time

$120 - $130 per hour

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Senior Manager IT Manufacturing Applications

Remote or San Diego, California

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Today

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 141,800.00 - 236,400.00 per year

Imaging Service Engineer I - Minnesota

Remote

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Today

Position Overview An Imaging Service Engineer I is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed by the Area Service Manager. 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 cutting-edge healthcare solutions span diagno

Full-time

USD 32.69 - 38.46 per hour

Iso 13485 jobs in Lake Forest, CA, USA