Iso 13485 jobs in irvine, ca

Irvine, California

•

Today

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. Support Release of OTS and custom parts Mechanical Drawing Review & Manufacturability

Full-time

Engineer II

Irvine, California

•

Today

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

Principal Engineer, Supplier Development

Irvine, California

•

Today

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and

Full-time

USD 121,000.00 - 171,000.00 per year

Sr Test Engineering Technician

Irvine, California

•

Today

Job Description Job Summary: The Test Engineering Technician supports the execution of verification, validation, reliability, and performance testing for Masimo products and technologies. This role is responsible for setting up and conducting tests, collecting and documenting data, maintaining laboratory equipment and test fixtures, and supporting engineering teams in the evaluation of products and systems. The Test Engineering Technician works closely with Test Engineering, Quality, and cross-

Full-time

USD 33.00 - 39.00 per hour

Senior Engineer, Product Development Engineering

Irvine, California

•

Today

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 Summary The Senior Engineer

Full-time

USD 105,500.00 - 168,800.00 per year

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

San Clemente, California

•

Today

Job Description Position Summary Provide quality support for ICU Medical Consumable development. The Quality Engineer will support activities such as CAPA investigations, 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 and processes such as product

Full-time

USD 90,000.00 - 129,000.00 per year

Software Project Lead

Irvine, California

•

Today

The Software Project Lead is responsible for coordinating and driving execution across multiple Agile software development teams to ensure predictable, high-quality delivery of software programs supporting ASP products and platforms. This role provides program-level leadership through cross-team planning, dependency management, risk mitigation, release coordination, stakeholder communication, and execution governance. The position works closely with Product Owners, Engineering Managers, Technica

Full-time

USD 137,200.00 - 229,100.00 per year

Engineer II, Algorithm

Irvine, California

•

Today

Job Description Job Summary: The Engineer II, Algorithm supports the design, development, testing, and optimization of advanced signal processing and physiological measurement algorithms used in Masimo's medical technologies and monitoring platforms. This role contributes to the development of next-generation noninvasive monitoring solutions through data analysis, modeling, experimentation, and cross-functional engineering collaboration. The Engineer II works closely with algorithm, software,

Full-time

USD 120,000.00 - 150,000.00 per year

Senior Engineer, Supplier Quality

Irvine, California

•

Today

Full-time

USD 105,500.00 - 168,800.00 per year

Principal, Software Engineer

Lake Forest, California

•

Today

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? The Principal Software Engineer, Medical Device Systems is res

Full-time

USD 128,350.00 - 166,100.00 per year

Auditor

Remote or Chicago, Illinois

•

Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

Easy Apply

Full-time

$40.0000 - $43.0000

Principal Opto-Mechanical Engineer

Lake Forest, California

•

Today

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role in our R&D location in Lake Forest, CA is part of Al

Full-time

USD 130,900.00 - 169,400.00 per year

Senior Software Verification & Validation Engineer

Irvine, California

•

Today

The Senior Software Verification and Validation Engineer is responsible for planning, developing, executing, and documenting software verification and validation activities for embedded software used in ASP capital systems. This role supports manual and automated testing, requirements-based verification, defect investigation, field issue investigation support, testing lab maintenance, and release readiness in a regulated medical device environment. The position works closely with Software Engine

Full-time

USD 101,200.00 - 169,050.00 per year

Cybersecurity Quality Engineer

Irvine, California

•

Today

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 Staff Software Advance Quality Engineer

Remote or Detroit, Michigan

•

Today

Work Flexibility: Remote or Hybrid or Onsite It's Time to Join Stryker! Why Join Us In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery. Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our

Full-time

USD 102,600.00 - 171,000.00 per year

Backend AI Engineer - Remote

Remote or San Diego, California

•

Today

Genesis10 is currently seeking a Backend AI Engineer - Remote for a contract position with a Global Medical Technology Company located in San Diego, CA. This is a 12+ month contract opportunity. This position is 100% remote. Compensation: $43.00 - $53.00 per hour, W2, based on qualifications Position Overview: This role focuses on developing and implementing generative AI solutions, including building robust RAG pipelines, fine-tuning LLMs, and creating high-performance APIs. The ideal candidat

Easy Apply

Full-time

Compensation information provided in the description

Staff Software Engineer

Remote or California

•

Today

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team me

Full-time

USD 140,000.00 - 160,000.00 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

•

Today

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

Senior Database Design Engineer

Remote

•

Today

Full-time

USD 100,000.00 - 120,000.00 per year

Iso 13485 jobs in Irvine, CA, USA