ISO 13485 jobs in California

Remote

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Today

Req ID: 132789 Region: Americas Country: USA State/Province: New Hampshire City: Remote Employee US Summary Senior commodity engineer with extensive experience in managing electronic component quality. Applicant must have experience working directly with suppliers to drive quality improvement activities through defect monitoring /reporting, corrective action processes, and supplier audits. Electronic component technical expertise required to interface with customers and suppliers on deep t

Sponsored

Full-time

Sr. Hardware, Manufacturing Engineer (Onsite)

Los Angeles, California

•

Today

We are seeking a hands-on Senior Hardware Manufacturing Engineer to support the design, development, and industrialization of tooling, fixtures, and production equipment for electro-mechanical medical devices. This role owns the hardware realization strategy-from early concept tooling through outsourced fabrication and production deployment. You will work closely with R&D, Quality, Operations, and suppliers to translate process requirements into robust mechanical solutions, lead tool design acti

Full-time

USD 117,000.00 - 175,000.00 per year

Senior Process Engineer (Onsite)

Los Angeles, California

•

Today

Our Ambition & Vision Our ambition is to build a next-generation, best-in-class supply chain that gives ResMed a true competitive advantage through outstanding value, quality, and availability. We strive to be a trusted partner that connects technology, people, and purpose to deliver exceptional outcomes for our customers and patients around the world. Our vision is to create an intelligent, connected, and reliable supply chain-transparent, data-driven, and always improving. By combining collabo

Full-time

USD 117,000.00 - 175,000.00 per year

Quality Engineer (Mechanical Product)

Santa Barbara, California

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Today

Leading Hardware Company This Jobot Job is hosted by: Emily Bohanon Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $140,000 - $175,000 per year A bit about us: We are an innovative technology company focused on designing and delivering premium hardware products that blend sophisticated engineering with seamless user experiences. Our teams work at the intersection of advanced electromechanical systems, precision manufacturing, and consumer-

Full-time

USD 140,000.00 - 175,000.00 per year

Quality Engineer - Soft Goods

Goleta, California

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Today

Leading Footwear & Apparel Brand! This Jobot Job is hosted by: Emily Bohanon Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $140,000 - $175,000 per year A bit about us: We are a global lifestyle and performance brand platform focused on designing, developing, and distributing premium footwear, apparel, and accessories. Our products blend innovation, comfort, and performance and are trusted by athletes, outdoor enthusiasts, and everyday con

Full-time

USD 140,000.00 - 175,000.00 per year

R&D Program Manager- MMS Project Management

San Diego, California

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18d ago

Position Title: R&D Program Manager MMS Project Management Location: Onsite San Diego, CA preferred, but will also entertain Remote options Start Date: ASAP Length of Contract: 6 months + extension Interview Process: 1st round on Teams with hiring manager for 30-45 minutes, 2nd round will consist of 2-3 other team leads. Background Check Required Scope: This Program Manager will lead a cross-functional Core Team through a critical compliance program to achieve full certification for medical elec

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Contract

$60 - $75

R&D Design Engineer II

Irvine, California

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Today

MUST HAVE MEDICAL DEVICE INDUSTRY EXP. Job Description: Position Title: R&D Design Engineer II Location: Onsite/Hybrid Role in Irvine, CA 92612 Contract Period: 12 Months Shift Timings: Mon - Fri, 08:00 AM - 05:00 PM PST Location: Irvine, CA - Hybrid Required (M/F Remote - T/W/TH Onsite) Contract: 1 year - based on performance and business needs Client is looking for a Development Engineer in the Irvine Engineering Testing & Analysis group (ETAG) within Device & Combination Product Developm

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Contract

Process Development Consultant

Remote or Almont, Colorado

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Today

Description: CONTEXT A growing medical device company specializing in steerable cardiac catheters is seeking an experienced Manufacturing Process Development & Scale-Up Consultant. Reporting to the CTO (Head of R&D & Operations), the consultant will lead efforts to transition low-volume manufacturing to outsourced, scalable production, including site selection, knowledge transfer, pilot implementation, and full-scale launch. Ideal candidates bring big-company, multi-step catheter manufacturing

Contract

Solution Architect

Remote

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3d ago

Hi, Job Title: PLM Principal Architect Job Location: Remote USA Job Type: Full Time Responsibilities: Must Have Skills 10+ years experience in Windchill Implementation Projects.Strong Windchill Implementation Knowledge and good understanding of Windchill Data Model.Understanding of the Life Sciences Domain.Windchill Solution Designing.Must Haves: Medical Device Exp, Exp in Windchill Implementation, Exp as Solution Architect. Basic understanding of processes including: ISO:13485ISO:1497121 CFR

Easy Apply

Full-time

Depends on Experience

Director of Preclinical & Clinical Science

Lawndale, California

•

Today

Overview The Director of Preclinical & Clinical Science is responsible for guiding Critical Innovations' preclinical, translational, and clinical-development strategy across the Company's product-development lifecycle. This role provides scientific leadership for preclinical research, translational evidence planning, early clinical-development strategy, clinical-study readiness, and scientific support for regulatory and sponsor-facing activities. The Director will lead the Company's Preclinical

Full-time

Compensation information provided in the description

Sr Process Engineer

Compton, California

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3d ago

Bachelors degree in Engineering required.710 years of experience in medical devices or similar fields.Hands-on experience with:Process validation and equipment qualificationTech transfer between international sitesData analysis and automationFiltration systems (Hollow Fiber, Flat Sheet Membranes)Strong knowledge of ISO 9001, ISO 13485, or GMP manufacturing standards.Proficient in SolidWorks/CAD, MS Office, and electronic file management systems.Familiarity with single-use systems, sterilization

Easy Apply

Contract

Depends on Experience

Supplier Manufacturing Engineer

Sunnyvale, California

•

Today

Primary Function of Position: The ideal Candidate has a track record of supporting new products launch, demonstrated collaboration with Contract Manufacturers, and preferred experience with multiple manufacturing methods, including various metal/plastics machining processes, treatments, and finishing processes. Plastic Injection Molding and Metal Injection Molding are preferred as well. The candidate also has skills in selecting and developing suppliers. Roles & Responsibilities:

Easy Apply

Contract, Third Party

$70 - $77

Component Engineer 4

Mountain View, California

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24d ago

Description: The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. Each supplier engineer is responsible for ensuring suppliers meet ISI requirements for product quality, cost, and service. Roles and Responsibilities: Part Qualification Support Value Engineering and Quality Improvement Part Qualification efforts Lead Core Product Teams in defining appropria

Easy Apply

Contract, Third Party

$94 - $94

Med Device Auditor

Remote

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7d ago

Job SummaryWe are seeking an experienced and detail-oriented Medical Device Auditor to evaluate and ensure compliance with medical device quality systems, regulatory requirements, and industry standards. The ideal candidate will conduct audits of manufacturing processes, quality management systems, supplier controls, and documentation practices to ensure compliance with FDA, ISO 13485, MDR, and other applicable regulations. The candidate should possess strong analytical skills, deep understandin

Easy Apply

Contract

Depends on Experience

Device Engineering Sr. Engineer

Remote or Cambridge, Massachusetts

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Today

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

Full-time

USD 115,494.60 - 156,257.40 per year

Senior Software Design Assurance (Sr Software Design Quality) Engineer

Remote

•

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 95,900.00 - 159,900.00 per year

Mgr Reliability Engineering

Remote or 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 102,000.00 - 177,100.00 per year

Engineer I, Software Quality

Remote

•

Today

Position Overview This position is intended to be an entry level position focused on software functional testing and quality assurance, and the fulfillment of relevant procedure and documentation per Fujifilm Medical Informatics Design Control process for software development. 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 soluti

Full-time

Staff Process Development Engineer

San Diego, California

•

Today

Full-time

USD 111,100.00 - 185,100.00 per year

Senior Staff Process Development Engineer

San Diego, California

•

Today

Full-time

USD 149,000.00 - 248,300.00 per year

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ISO 13485 jobs in California, USA