ISO 13485 Jobs

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Sr. Firmware Engineer

Jobot

Overland Park, Kansas, USA

Full-time

Come Grow with Us! Direct Hire Opportunity with Full Benefits. This Jobot Job is hosted by: Brooke Meyer Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $86,000 - $150,000 per year A bit about us: Leading product development, design, engineering, and manufacturing firm. We offer a unique suite of product design services with the expertise to deliver only the most effective solutions. Why join us? Opportunity for growth and advancementCompe

Sr. Manufacturing Engineer

BAXTER

Hilltop, Minnesota, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h

Sr. Manufacturing Engineer

BAXTER

South Saint Paul, Minnesota, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h

Sr. Manufacturing Engineer

BAXTER

Houlton, Wisconsin, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h

Sr. Manufacturing Engineer

BAXTER

Saint Paul, Minnesota, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h

Sr. Manufacturing Engineer

BAXTER

Savage, Minnesota, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h

Senior Reliability Engineer

GE Healthcare

Waukesha, Wisconsin, USA

Full-time

Job Description Summary The Senior Reliability engineer will be an integral part of the central DFR (Design for Reliability) program team within the STO org partnering with GEHC modality engineers, reliability leaders, and external vendors (ASQ, etc.) to support the development and deployment of the standard GEHC DFR methodology applying relevant reliability concepts, processes, standards, and tools. Activities include providing Sub Matter Expertise (SME) in assessing and quantifying tech (relia

Validation Engineer

Katalyst Healthcares and Lifesciences

Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends

Engineer

Katalyst Healthcares and Lifesciences

New Jersey, USA

Full-time

Job Description: Primary "essential" duties and responsibilities. Interprets customer specifications to define requirements for mechanical designs. Performs first principal analysis related to appropriate aspects of mechanical design. Applies the 3D CAD system to create mechanical design and drawings. Develops detailed fabrication and assembly drawings and performs tolerance analysis. Develop prototypes for design evaluation. Troubleshoot and resolve design & processing issues. Contribut

EMS Validation Engineering Lead

Schneider Electric

Horsham, Pennsylvania, USA

Full-time

What will you do? As an EMS Validation Engineering Lead, you will play a lead role in ensuring Schneider Electric's (SE's) Environmental Monitoring System (EMS) deployment meets all industry, regulatory, and customer requirements. This position will be responsible for supporting all aspects of our Life Science projects, from our pre-construction and sales activities, through design and Implementation, to our service and maintenance programs. This position requires a strong blend of project tea

Senior Engineer, Quality

ICU Medical, Inc.

Salt Lake City, Utah, USA

Full-time

Job Description The Senior Quality Engineer (Quality Operation) provides hands-on technical quality engineering support and direction in quality assurance and quality control aspects of the SLC operation to facilitate an environment of compliance and meeting business objectives. The position requires good knowledge on the disciplines within a medical device QMS and knowledge and understanding of manufacturing, quality control processes and risk management. The incumbent will focus on verificati

Supplier Engineer II

Johnson & Johnson

Remote or Danvers, Massachusetts, 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

Senior Development Engineer - Plastic Products

Merck KgaA

Bedford, Massachusetts, USA

Full-time

Work Location: Bedford, Massachusetts Shift: No Department: LS-PS-RUB1 Single Use Products 1 Recruiter: Troy Bradley This information is for internals only. Please do not share outside of the organization. Your Role We are currently seeking a Senior Development Engineer: Plastic Product Design for a role within the Single Use and Integrated Systems R&D group at MilliporeSigma Process Solutions business unit. In this position, the individual will be responsible for developing innovative plasti

Principal Software Engineer - Urology R&D

Boston Scientific Corporation

Arden Hills, Minnesota, USA

Full-time

Additional Location(s): US-MA-Marlborough 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 -

Senior Electrical Engineer

Boston Scientific Corporation

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. Senior Electrical

Principal Process Engineer - OPEX

Cardinal Health

Chicopee, Massachusetts, USA

Full-time

Job Summary We are seeking a highly motivated and experienced Principal Process Engineer to join our team and lead continuous improvement initiatives within our medical device manufacturing facility. The ideal candidate will have a strong background in Lean Six Sigma methodologies and project management, with a proven track record of successfully implementing process improvements that enhance efficiency, productivity, and quality. The ideal candidate will have a breadth of experience gained from

Document Specialist V

OrangePeople

Sunnyvale, California, USA

Contract

OP is currently looking for a Document Control Analyst who will support product programs by managing standard operating procedures, work instructions, forms, and all types of records from product concept through obsolescence for a leading social media company. The Document Control Analyst has knowledge and experience working in regulated environments (i.e., ISO 13485) and sufficient knowledge and experience to be able to operate with minimal supervision. You are flexible, responsive, detail-orie

Mechanical Engineering Associate

Johnson & Johnson

Santa Clara, California, 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

Software Architect - Embedded

Motion Recruitment Partners, LLC

Bedford, Massachusetts, USA

Full-time

This is an opportunity to join a global leader in the development of innovative diagnostic technologies. Driven by a commitment to improving patient care, the company focuses on delivering integrated, high-quality diagnostic solutions that enhance clinical outcomes and hospital efficiency. The Embedded Software Architect will serve as a key technical leader across multiple software product lines. This role is responsible for defining and enforcing architectural best practices, guiding the integ

Software Test Engineer

Johnson & Johnson

Santa Clara, California, 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