medical devices Jobs in california

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Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

Walnut Creek, California, USA

Full-time

Job Description: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil

Sr Engineer, Embedded GUI Software

Masimo Corporation

Irvine, California, USA

Full-time

Job Description Job Summary: As an Embedded GUI Software Engineer, you will design, develop, and implement applications for our next generation patient monitoring devices. Day to day: Develop GUI applications for our medical devices Design, Implementation and Maintenance of Software Peer design/code review Software Documentation Software Specification and Testing Requirements: Strong fundamentals in computer graphics Experience with C++ software development experience Experience with graphica

System Validation Engineer

Katalyst Healthcares and Lifesciences

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi

Systems Engineer - R&D

Stryker

Irvine, California, USA

Full-time

Work Flexibility: Onsite What You Will Do: The R&D Engineer supports the design changes of commercialized devices and international submissions in the Inari Medical Division, including writing or verifying specifications, designing device improvements and fixtures, and conducting testing to adhere to product requirements and regulatory standards. Design, develop, and verify mechanical components for medical devices under supervision, contributing to the overall engineering process.Support pro

Senior Technical Writer

Kforce Technology Staffing

Remote or Acton, Massachusetts, USA

Contract

RESPONSIBILITIES: Kforce has a client that is seeking a Senior Technical Writer in Acton, MA. Summary: We're seeking a Senior Technical Writer to support UX design documentation for a regulated platform. This role focuses on creating and managing technical content such as design specifications, microcopy, and graphical requirements documentation. In this role, you will collaborate with cross-functional teams across regions to ensure clarity, consistency, and compliance with quality standards.

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

Software Quality Engineering Lead

Johnson & Johnson

Remote or New Brunswick, New Jersey, USA

Full-time

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

Validation Engineer

Katalyst Healthcares and Lifesciences

Irvine, California, USA

Full-time

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives. Responsibilities: Interpret and implement validation requirements based on FDA regulations, corporate stan

Associate Director, Strategic Data Integration

Becton Dickinson & Company

San Diego, California, USA

Full-time

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

Principal Engineer- CPO Primary Container Engineering

Amgen Inc

Thousand Oaks, California, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients eac

Field Service Engineer 1

GE Healthcare

Remote

Full-time

Job Description Summary Job Summary The Field Service Engineer provides customer site support for all products within their assigned area of responsibility. The FSE serves as the technical liaison between the customer and manufacturing operations. They are responsible for maintaining and repairing equipment on-site and returning it to operational status as quickly as possible while minimizing service costs. This position requires the ability to work independently or in a team environment, must h

Engineer III, Systems Engineer

Katalyst Healthcares and Lifesciences

San Diego, California, USA

Full-time

Responsibilities: Verification & validation Engineer will have the following responsibilities: A strong technical background and experience g in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical

IT Business Relationship Manager - (North America Sales Operations)

Abbott Laboratories

Alameda, California, USA

Full-time

Job DescriptionAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a

Sr Engineer, GUI Software

Masimo Corporation

Irvine, California, USA

Full-time

Job Description Job Summary As a Sr Engineer, Instrument Software you will design, develop, and implement applications for our next generation handheld patient monitoring devices. The selected candidate will develop the user interface working closely with our UX designers to develop the backend framework for our devices. Develop UI frameworks for the interface of our medical devices. Work closely with our UX designers to develop the backend framework Design, Implementation and Maintenance of

Engineer - Complaints Technical Investigator

Amgen Inc

Thousand Oaks, California, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients ea

SAP BASIS System Administrator

Novanta Inc

Remote

Full-time

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

IT Business Relationship Manager - (North America Sales Operations)

Abbott Laboratories

Alameda, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo

Senior Process Engineer III

Katalyst Healthcares and Lifesciences

Dublin, California, USA

Full-time

Responsibilities: Design History File: Ensure that the transferred process is adhering to the Device Master Record. Process Analysis and Documentation: Analyse current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facilities. Transfer Planning: Develop and implement a comprehensive transfer plan, including timelines, resources, and risk assessments, to ensure smooth transition between facilities. Cross-functional Collaboration:

Staff Engineer, Design Quality - Inari Medical

Stryker

Irvine, California, USA

Full-time

Work Flexibility: Onsite Stryker - Inari Medical is hiring a Staff Engineer, Design Quality in Irvine, California! In this role, you will partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes that support new product development projects. You will also lead risk management activities to ensure the highest level of product and process quality! What You Will Do: Develop quality documentation to support new product development and regul

Sr Engineer II, Systems Software

Masimo Corporation

Irvine, California, USA

Full-time

Job Description Are you an experienced Sr Engineer looking to join an innovative team focused on creating innovative next generation medical devices affecting patient lives? If so, Masimo may be the place for you! We are looking for a Sr Engineer II, Systems Software to join our team at our Irvine, CA headquarters. Responsibilities: Architect and develop system-level solutions for dashboards, networked communications, and alarm notification systems to integrate seamlessly with medical devices.