ISO 13485 Jobs

61 - 80 of 143 Jobs

Engineer Disposables and SustainingJob Title - Engineer Disposables and Sustaining

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Responsibilities: Create new 3rd party supplier documentation including design specifications, labelling, design drawings, etc. for peritoneal dialysis disposable sets. Create, modify, and maintain design history files. Perform change control assessments. Work closely with project manager and technical lead to achieve project commitments. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Requirements:

Medical Device EngineerJob Title - Medical Device Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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North Chicago, Illinois, USA

Full-time

Responsibilities: 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 software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi

Engineering Documentation ExpertJob Title - Engineering Documentation Expert

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Fort Worth, Texas, USA

Full-time

Responsibilities: Develop comprehensive technical documentation, including user manuals, installation guides, labeling materials, and regulatory documentation for ophthalmic devices. Work closely with engineering, regulatory, and quality teams to ensure all documentation meets industry standards and regulatory requirements. Interpret engineering drawings and specifications to create detailed build and qualification procedures for complex ophthalmic systems. Collaborate with R&D and manufacturing

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot

Engineer IIIJob Title - Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Flemington, New Jersey, USA

Full-time

Roles & Responsibilities: Process non-conformances and CAPAs following approved procedures. Perform investigations and assist in problem solving following approved methodologies. Partners with engineering, production, maintenance, etc. to maintain/increase the quality level within the organization. Ensures local issues are incorporated into global total quality management plans, taking legal requirements and local manufacturing processes into consideration. Monitors quality control processe

Automation Control EngineerJob Title - Automation Control Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa

Medical Device System Test EngineerJob Title - Medical Device System Test Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Raleigh, North Carolina, USA

Full-time

Responsibilities: Develop system and subsystem-level design specifications based on requirements. Develop system and subsystem-level configurations. Develop system and subsystem-level test methods and protocols. Serve as design transfer liaison to Manufacturing, Service, Support, and Training. Serve as technical support for key products to our customers, dealers and field engineers. Prototype and test new circuit boards and improved revisions of existing circuit boards following medical de

Injection Molding EngineerJob Title - Injection Molding Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Jacksonville, Florida, 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

Injection Mold EngineerJob Title - Injection Mold Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Jacksonville, Florida, USA

Full-time

Validation Engineer, Sterile & CleaningJob Title - Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute

Principal R&D EngineerJob Title - Principal R&D Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Leads design and development of product changes within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Schedule, budget, and lead engineering projects with minimal guidance. Serve as the technical expert for design

Principal System EngineerJob Title - Principal System Engineer

FlextronicsCompany Name - Flextronics

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Hollis, New Hampshire, USA

Full-time

Job Posting Start Date 04-22-2025 Job Posting End Date Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job

Software Quality EngineerJob Title - Software Quality Engineer

FlextronicsCompany Name - Flextronics

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Austin, Texas, USA

Full-time

Job Posting Start Date 06-11-2025 Job Posting End Date 08-18-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord

Validation Engineer NPIJob Title - Validation Engineer NPI

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irving, Texas, USA

Full-time

Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical

System Validation EngineerJob Title - System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Principal Software Architect - Clinical Imaging Software (Plymouth, MN or Cambridge, MA)Job Title - Principal Software Architect - Clinical Imaging Software (Plymouth, MN or Cambridge, MA)

Philips North AmericaCompany Name - Philips North America

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Plymouth, Minnesota, USA

Full-time

Job Title Principal Software Architect - Clinical Imaging Software (Plymouth, MN or Cambridge, MA) Job Description Principal Software Architect- Clinical Imaging Software (Plymouth, MN or Cambridge, MA) We are seeking an experienced and visionary Principal Software Architect to lead the architectural direction of our Clinical Imaging Software portfolio for the Image Guided Therapy Devices (IGT-D) business. As a key member of the Software Leadership team, you will be responsible for shaping in

Sr. Engineer Disposables R&D, SustainingJob Title - Sr. Engineer Disposables R&D, Sustaining

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/Client, cost reduction, remediation). Identify, investigate, and solve engineering problems utilizing risk-based and customer focused app

Software Verification EngineerJob Title - Software Verification Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Newton, Massachusetts, USA

Full-time

Job Description: We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects. Responsibilities: Test Planning and Design. Develop comprehensi

Medical Device & Regulations EngineerJob Title - Medical Device & Regulations Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Systems EngineerJob Title - Systems Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Skaneateles, New York, USA

Full-time

Responsibilities: Responsible for integration of design and manufacturing process procedures, templates and guidance documents within an ISO 13485 compliant Quality Management System (QMS). Demonstrated ability to communicate with a wide set of stakeholders (Quality, Systems/Risk, PM, RA, Marketing, etc.). Demonstrated understanding of the end-to-end process of identifying stakeholder needs, translation to Design Inputs and tracing these to the Design Outputs. Demonstrated understanding of Syste