ISO 13485 jobs in Fort Myers, FL

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

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Full-time

Sr. Packaging Process Engineer

Fort Myers, Florida

•

Today

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better . We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insura

Full-time

To define

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

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Full-time

Depends on Experience

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

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Contract

Depends on Experience

Device Engineering Sr. Engineer

Remote or Cambridge, Massachusetts

•

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

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

Mgr Reliability Engineering

Remote or Irvine, California

•

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

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

Imaging Service Engineer I - Milwaukee/Madison, WI/Chicago, IL

Remote

•

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 diagn

Full-time

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

Senior Specialist, Drug/Device Combo Products Engineer - Hybrid

Remote or Rahway, New Jersey

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Today

Job Description This position is in our organization's Device Development & Technology (DD&T) group in our Research division. Our organization's DD&T group is responsible for the development of devices, combination products, processes, testing and assembly equipment from conception through product launch. Products include injectors, inhalers, implants, infusion pumps, vaginal rings and connected devices/apps. The person in this position contributes to high impact, complex, cross-functional, and

Full-time

USD 117,000.00 - 184,200.00 per year

Staff Engineer

Remote or Lawrence, Massachusetts

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Today

Position Summary: We are looking for a highly technical Staff Systems Engineer who will play a key role in the design and development dialysis instruments at NxStage Medical. He or she will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment. This individual will lead systems engineering related activities on product development programs, exhibiting outstanding verbal and written communication skills. Core Responsibilities: Leads the development and mai

Full-time

USD 131,000.00 - 220,000.00 per year

Engineer, Spine R&D

Remote or Raynham, Massachusetts

•

Today

Full-time

USD 76,000.00 - 121,900.00 per year

Software Engineer for Medical Informatics, hybrid role in Durham, NC (TypeScript, C++, C#)

Remote or Durham, North Carolina

•

Today

Position Overview This position is for a Senior Software Engineer to join our healthcare imaging and informatics team. This opportunity is to develop software solutions to empower medical professionals in the fields of radiology and cardiology to help them effectively diagnose patients. As part of the Visualization Team, the role will work on innovative imaging technologies to present medical images and their associated data to healthcare practitioners. Company Overview At FUJIFILM Healthca

Full-time

Mechanical Engineer - Robotic Systems

Remote or Santa Clara, California

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Today

Full-time

Sr NPI Engineer

Remote or Danvers, Massachusetts

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Today

Full-time

USD 94,000.00 - 151,800.00 per year

Senior Mechanical Engineer - Robotics R&D

Remote or Santa Clara, California

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Today

Full-time

USD 125,000.00 - 201,250.00 per year

Senior Upgrade Engineer, Medical Informatics: Radiology & Cardiology PACS, Mobility, EIS, and Synapse

Remote

•

Today

Position Overview The Senior Upgrade Engineer is responsible for performing upgrades for Fujifilm Healthcare Americas Corporation (HCUS) Medical Informatics (MI) products to all eligible sites. In addition will maintain necessary documents and process information regarding upgrades. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally re

Full-time

Quality Analyst

Remote or Bridgewater, Massachusetts

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Today

Kelly Science and Clinical FSP is currently seeking a Quality Analyst for a long-term engagement in Raynham, MA with one of our Global Medical Device clients. This position is onsite. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits

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ISO 13485 jobs in Fort Myers, FL, USA