ISO 13485 Jobs

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Automation Engineer

Becton Dickinson & Company

•

El Paso, Texas, USA

Full-time

Job Description Summary This role will master the Automated equipment Technology, will use their knowledge and experience in Automation techniques to assist production in the resolution of complex equipment breakdowns or inefficiencies as well as development, implementation of equipment re-design to improve efficiency and or reduce downtime due to repetitive parts failures. Lead and/or participate in activities related to CAPA (Corrective and Preventive Actions), QNs (Quality Notifications) and
Posted 60+ days ago | Updated 1 hour ago

Engineer Sr I - Manufacturing - (Mechanical & Electrical) 1

Arthrex

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Goleta, California, USA

Full-time, Contract

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
Posted 52 days ago | Updated 3 hours ago

Senior Manager Software Engineering

Boston Scientific Corporation

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Arden Hills, Minnesota, USA

Full-time

Innovation - Diversity - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Senior Software M
Posted 60+ days ago | Updated moments ago

Principal Software Engineer - Urology R&D (Mobile Applications)

Boston Scientific Corporation

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Irvine, California, USA

Full-time

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your
Posted 8 days ago | Updated moments ago

Principal Software Engineer - Urology

Boston Scientific Corporation

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Irvine, California, USA

Full-time

Innovation - Diversity - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the Role:
Posted 40 days ago | Updated 1 hour ago

Senior Automation and Robotics Software Engineer

LabCorp

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Connecticut, USA

Full-time

Location: Bloomfield, CT Company: Protedyne, a subsidiary of Laboratory Corporation of America About Us Protedyne combines the design principles of industrial automation with cutting-edge robotic hardware and software infrastructure to deliver comprehensive data management and process tracking solutions. As part of Labcorp, our mission is to develop smarter, faster automation solutions that include robots to optimize efficiency in diagnostic testing laboratories worldwide. We are seeking a Se
Posted 60+ days ago | Updated 1 hour ago

Senior Engineer, Design Transfer Specialist

Amgen Inc

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Remote or Cambridge, Massachusetts, USA

Full-time

Career Category Operations 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 each
Posted 60+ days ago | Updated 1 hour ago

Validation Engineer

Source Code Technologies LLC

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Sunnyvale, California, USA

Contract

Role name: Validation Engineer Branch | City | Location: Sunnyvale/ Santa Clara, CA Duration: 6 Months Keywords: Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304 Role 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 sof
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Posted 6 days ago

Senior Quality Engineer

Catapult Solutions Group

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Chicopee, Massachusetts, USA

Full-time

Senior Quality EngineerQuality Engineering Department Location -Chicopee, MA - On-site position Role Type Full-time position About Our ClientOur client is an established manufacturing company specializing in sealed plastic film products for multiple industries, with a particular focus on medical device manufacturing. Operating in an ISO 13485 certified environment, they maintain the highest standards of quality and regulatory compliance. The company serves diverse markets requiring stringent qua
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Posted 10 days ago

Hiring- Software Engineer / R & D Software Engineer

Recruitment.ai

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Tennessee City, Tennessee, USA

Contract

Job Title: Software Engineer / R&D Software Engineer Location: East Tennessee - Hybrid Position Summary Software Engineers and R&D Software Engineers to join a growing development team. These roles will involve designing and developing advanced medical imaging software solutions used in orthopedic diagnostics and computer-assisted surgery. As a member of our team, they will work in a collaborative, fast-paced environment where innovation and excellence are highly valued. You will play a key role
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Posted 10 days ago

AI Program Manager

Stellar IT Solutions

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Oldsmar, Florida, USA

Full-time, Part-time, Contract, Third Party

Job Title: AI Program Manager Job Location: Oldsmar, FL Interview: Virtual Job Duration: 1 year+ Job Description We are looking for an experienced and well-rounded AI Program Manager to lead the organization's AI initiatives. This role focuses on driving responsible adoption of AI tools, delivering organization-wide training, managing change, and ensuring all AI-related efforts comply with internal standards and regulatory requirements. While project management certifications are a plus, dee
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Posted 11 days ago | Updated 1 hour ago

Operations Quality Engineer

Randstad Digital

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Minneapolis, Minnesota, USA

Full-time

job summary: Here's a short, attractive, and engaging LinkedIn post to promote the Operations Quality Engineer role: ? Elevate Medical Device Quality! ? We're searching for an experienced Operations Quality Engineer to join a rapidly growing medical device manufacturer. If you're passionate about optimizing QMS, driving compliance (FDA 21 CFR 820, ISO 13485), and working hands-on with cutting-edge products like catheters, this is your chance to make a real impact! This on-site role in Minnea
Posted 7 days ago | Updated moments ago

Firmware / Controls Engineer

Sunrise Systems, Inc.

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Durham, North Carolina, USA

Contract

Our client, a leading medical devices manufacturing company, is looking for a Firmware / Controls Engineer. This is for an initial duration of 12 months and is located in Durham, NC. Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship) Job Description: Responsible for designing, developing, and testing all aspects of automation and robotic motion control systems.This well-rounded engineer will apply their knowledge of software, electrical, and mechanical engineerin
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Posted 24 days ago | Updated 6 hours ago

Project Manager

Stellar IT Solutions

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Madison, Wisconsin, USA

Full-time, Part-time, Contract, Third Party

Job Title: Project Manager Sustaining Engineering & Fixture Development Location: Onsite Madison, WI Job Type: Full-Time / Contract Industry: Medical Devices / Engineering / Manufacturing Job Summary: We are seeking a skilled and detail-oriented Project Manager with a background in engineering to lead and manage multiple sustaining engineering and fixture development projects within a regulated medical device environment. This role will be based onsite in Madison, WI and will involve collabor
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Posted 22 days ago | Updated 1 hour ago

Principal Engineer/Product Manager

Randstad Digital

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Minneapolis, Minnesota, USA

Full-time

job summary: ? Lead Innovation in Med Devices! ? Are you a Principal Engineer/Program Manager with 10+ years of engineering and 7+ years of project management experience in medical devices? We're seeking a hands-on leader to drive complex product development programs in Brooklyn Park, MN! If you're passionate about bringing cutting-edge medical technologies to life, this is your opportunity to lead and make a significant impact. #MedicalDevices #ProgramManager #EngineeringJobs #NowHiring #Pr
Posted 7 days ago | Updated moments ago

Engineer Disposables R&D, Sustaining

Stefanini

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Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Vipul Bhardwaj - call: / email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.Create, modify, and maintain design history files.Perform change control assessments.
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Posted 10 days ago | Updated moments ago

Functional Test Engineer

HMG America

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Redwood City, California, USA

Contract, Third Party

HMG America LLC is the best Business Solutions focused Information Technology Company with IT consulting and services, software and web development, staff augmentation and other professional services. One of our direct clients is looking for Functional Test Engineer in Redwood city,CA. Below is the detailed job description. Title - Functional Test Engineer Location: Redwood city,CA - Onsite Job DescriptioN The Software Test Engineer will be responsible for writing test procedures, test reports
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Posted 24 days ago | Updated moments ago

Principal Engineer Disposables R&D, Sustaining

Stefanini

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Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Principal Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Tuhin Podder- call: /email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Technical lead for DHF structure within sustaining engineering for disposable medical devices.Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.Manage change controls from initiation th
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Posted 10 days ago | Updated moments ago

Principal Engineer Disposables R&D, Sustaining

Pyramid Consulting, Inc.

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Plymouth, Minnesota, USA

Contract

Immediate need for a talented Principal Engineer Disposables R&D, Sustaining. This is a 17+months contract opportunity with long-term potential and is located in Plymouth, MN (Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID:25-77915 Pay Range: $50 - $51/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan. Key Responsibilities: Manage new 3rd party supplier documentation strategy for p
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Posted 10 days ago

Principal Engineer - Disposables R&D, Sustaining - Hybrid

DivIHN Integration Inc.

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Plymouth, Minnesota, USA

Contract

DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our open positions. Please apply o
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Posted 5 hours ago | Updated 2 hours ago