iso 13485 Jobs

Refine Results
1 - 20 of 152 Jobs

Senior Human Factors Engineer

Medline Industries, LP

•

Northfield, Illinois, USA

Full-time

Job Summary This position is responsible for leading and conducting Human Factor/Usability activities to ensure medical devices (Class I and Class II) are safe to use in various user environments. This engineer will collaborate with design engineers and divisional teams to improve the product designs (New and existing), specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for misuse and/or use errors. The eng
Posted 34 days ago | Updated 7 hours ago

C++ Engineer

Recruitment.ai

•

Tennessee City, Tennessee, USA

Third Party, Contract

Qualifications Bachelor s, Master s, or Ph.D. in Computer Science, Biomedical Engineering, Electrical Engineering, or related fieldsStrong programming skills in C++ (required)Experience with the Qt platform for cross-platform GUI developmentBackground in medical imaging, biomedical engineering, or application software developmentExperience with computer-assisted surgery (CAS) is a major plusR&D experience, especially in regulated environments, is a strong advantageStrong problem-solving skills a
Easy Apply
Posted 17 days ago

R&D Staff Product Engineer

Thermo Fisher Scientific

•

Rochester, New York, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description What You'll Get to Do: As a Product Design Engineer, you will work in a new product development environment that support a wide variety of plastic labware products from concept to launch. Your ideas will bring new products to life as you collaborate with other design engineers, process development engineers, product managers and project leaders to develop products for life science, medical device, laboratory, di
Posted 21 days ago | Updated 10 hours ago

Principal Software Test Engineer - Embedded Systems / Medical Devices

Stryker

•

Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid or Onsite The Principal Software Test Engineer - Embedded Systems / Medical Devices will be responsible for leading the verification and validation (V&V) of embedded software in our Class I, II, & medical devices. This role is critical to ensuring our products meet the highest standards of quality, safety, and regulatory compliance. The ideal candidate will bring deep expertise in embedded systems, test automation, and software testing within regulated environments (IE
Posted 10 hours ago

Controls Engineer III

Thermo Fisher Scientific

•

Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. Discover Impactful Work: You will be part of the manufacturing engineering team to develop new manufacturing equipment that
Posted 30 days ago | Updated 10 hours ago

Principal Engineer, Product Transfer

Stryker

•

Salt Lake City, Utah, USA

Full-time

Work Flexibility: Hybrid Who we want- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insig
Posted 49 days ago | Updated 10 hours ago

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
Posted 4 days ago | Updated 10 hours ago

Process Engineer III

Thermo Fisher Scientific

•

Lebanon, Tennessee, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you join us at Thermo Fisher Scientific, you'll be part of a team that shares your passion for exploration and discovery! Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical
Posted 10 days ago | Updated 10 hours ago

Junior Medical Devices Quality Associate (2 Openings)(ONSITE)(No C2C/H1B)

NetSource, Inc.

•

Cedar Creek, Texas, USA

Contract

(No C2C/H1B) Please note that this is a 6 to 18-month contract position. Only local candidates need to apply. Notes: needs to have medical device or life science experience. Also should understand these compliance terms: Ensures compliance with relevant regulations and guidelines, ISO 13485, 21 CFR Paart 820, and IVDR. Qualifications Bachelor s degree required.1-2 years relevant quality experience in a manufacturing environment.1+ years of SAP experience.Focused on product release processes, e
Easy Apply
Posted 3 hours ago | Updated 2 hours ago

SUD Validation Engineer

Thermo Fisher Scientific

•

Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 27 days ago | Updated 10 hours ago

CAPAs Quality Engineer (2 Openings)(ONSITE)(No C2C/H1B)

NetSource, Inc.

•

Cedar Creek, Texas, USA

Contract

(No C2C/H1B) Please note that this is a 12 to 18-month contract position. Job Posting Qualifications Bachelor s or Master s Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred.4+ years of experience in a similar position within the Life science/Pharma industry.Medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is re
Easy Apply
Posted 3 hours ago | Updated 2 hours ago

Plastics Process Engineer

Jobot

•

Tampa, Florida, USA

Full-time

Drive Process Excellence in Class I- Medical Device Manufacturing This Jobot Job is hosted by: Ryan Weingardt Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $85,000 - $95,000 per year A bit about us: We are a Florida-based injection molder specializing in high-precision, low-to-mid volume production for the medical device and life sciences industries. With ISO Class 7 and 8 cleanroom capabilities and a track record of producing Class I, II
Posted 1 day ago | Updated 2 hours ago

Senior Supplier Quality Engineer

Jobot

•

Aurora, Colorado, USA

Full-time

Full-Time & Direct Hire Senior Supplier Quality Engineer needed for Global Health-Tech Leader! This Jobot Job is hosted by: James Thai Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $90,000 - $120,000 per year A bit about us: Based in Colorado Springs, CO, we are reimagining healthcare through breakthrough technologies and human-centered design. Our company is a global leader in health innovation, creating smart systems that improve lives
Posted 1 day ago | Updated 2 hours ago

Manufacturing Engineer

3D Systems Corporation

•

Littleton, Colorado, USA

Full-time

Description What We Are Looking For We are seeking a driven entry-level engineering professional with an interest in developing robust manufacturing processes and supporting technical projects. The Manufacturing Engineer will focus on medical, industrial, and aerospace applications at the 3D Systems manufacturing facility in Littleton, Colorado. This role will be an integral part of a cross-functional team working to achieve site, project, and program goals. Join our innovative team where you'
Posted 2 days ago | Updated 1 day ago

Engineer Disposables and Sustaining

Rose International

•

Plymouth, Minnesota, USA

Full-time

Date Posted: 07/11/2025 Hiring Organization: Rose International Position Number: 485371 Industry: Healthcare Job Title: Engineer Disposables and Sustaining Job Location: Plymouth, MN, USA, 55441 Work Model: Onsite Employment Type: Temp to Hire FT/PT: Full-Time Estimated Duration (In months): 12 Min Hourly Rate($): 30.00 Max Hourly Rate($): 35.00 Must Have Skills/Attributes: Creo, DFMEA, Medical device, Sterilization Experience Desired: Experience in Class II or Class disposables medical
Easy Apply
Posted 16 days ago | Updated 7 hours ago

Mechanical Engineer

Jobot

•

Vista, California, USA

Full-time

Excellent Opportunity to Join a Fast Growing Manufacturing Company! Competitive Salary and Stellar Benefits! This Jobot Job is hosted by: Jaclyn D'Amore Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $85,000 - $100,000 per year A bit about us: We are seeking an experienced Manufacturing Engineer with a strong background in project management and regulated manufacturing environments. This individual will drive continuous improvement, optimi
Posted 2 days ago | Updated 2 hours ago

Design/Process Engineer

Jobot

•

Saint Paul, Minnesota, USA

Full-time

Design/Process Engineer needed for leading Medical Device Manufacturer! This Jobot Job is hosted by: Jacob Hummel Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $80,000 - $150,000 per year A bit about us: Our organization is an ISO 13485:2016 certified and FDA-registered contract manufacturer specializing in custom plastic injection molding and assembly of medical devices. Our company offers comprehensive services from rapid prototyping to
Posted 3 days ago | Updated 2 hours ago

Assoc Engineer Process

Medline Industries, LP

•

California, USA

Full-time

Job Description Main responsibilities: Production support to meet performance and quality metricsProduction lines improvementOperations and process standardizationAnalysis of times and movementsProvide corrective and preventive actionsCost reduction projectsSupport and participate in the 5s program and Kaizen eventsResponsible for following the codes of conduct, regulations and policies of MedlineOthers responsibilities that could be assigned in the procedures of the quality systemQuality-Redu
Posted 33 days ago | Updated 7 hours ago

Manufacturing Engineer II - Onsite Wilsonville OR

TE Connectivity

•

Wilsonville, Oregon, USA

Full-time

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview The successful candidate will efficiently provide high-quality engineering solutions to complex manufacturing and business problems. The Manufacturing/Process Engineer will drive improvement using industry best practices and standardize work. Work will be completed according to TE Connectivity's SOPs within an ISO 13485 environm
Posted 4 hours ago

Teamcenter Quality Solution Architect

Intelizign

•

Remote

Full-time

Teamcenter Quality Solution Architect (U.S. Based)Location: Remote / Hybrid (U.S. Persons Only)Travel: 25 50%Industry Focus: Aerospace & Defense, Automotive, CPG, Medical Devices We are looking for a Teamcenter Quality Solution Architect to drive the successful deployment of best-in-class quality management solutions across multiple industries. This role plays a key part in helping customers unlock the full value of the Digital Thread using Siemens' Teamcenter Quality and Manufacturing Operatio
Easy Apply
Posted 27 days ago