iso 13485 Jobs

81 - 100 of 137 Jobs

EngineerJob Title - Engineer

ACL DigitalCompany Name - ACL Digital

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Thousand Oaks, California, USA

Full-time

Onsite This position reports into the Combination Product Operations Development and Lifecyle Management group in Thousand Oaks, CA. The candidate will support senior staff in device development, characterization, and verification of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects. This role will be required t

Engineering Technician- Temp ContractJob Title - Engineering Technician- Temp Contract

10x GenomicsCompany Name - 10x Genomics

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Pleasanton, California, USA

Full-time

About the role: We are seeking an organized, detail-oriented, problem-solving individual to join our Life Cycle Engineering team. The successful candidate will have strong attention to detail, great communication skills, ability to prioritize a variety of tasks, and the ability to work independently in a fast-paced environment. The Engineering Technician supports engineers so they can keep developing our manufacturing workcells and equipment. Our products have allowed researchers to study biolo

Senior Hardware Test EngineerJob Title - Senior Hardware Test Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Santa Rosa, California, USA

Full-time

Responsibilities: Perform hardware functional verification and testing. Develop and update hardware test protocols for medical device hardware components. Perform design specifications review and approval for new and existing medical devices. Identify and validate alternative components to address obsolescence issues in medical device hardware. Collaborate with cross-functional teams to ensure compliance with regulatory standards and quality requirements. Contribute to risk analysis and ma

R&D EngineerJob Title - R&D Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Santa Rosa, California, USA

Full-time

Roles and Responsibilities: Prepare test protocols and completion reports. Conduct testing in the lab, understand flow of events and need-by timelines, coordinate and communicate with all parties and mitigate any problems that arise. Perform test method and fixture updates including test method validation and equipment IQs etc. Responsible for Initiating Build Requests with the manufacturing team. Knowledge about tensile strength testing, fatigue testing, pressure testing, torque testing et

Sr. Instrument Verification and Validation EngineerJob Title - Sr. Instrument Verification and Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Rochester, New York, USA

Full-time

Job Description: Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manual test case design and execution of test procedures in a BL2 lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with so

EngineerJob Title - Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Los Angeles, California, USA

Full-time

Roles & Responsibilities: 4-6 years Minimum bachelor's or master's degree in a health-care related field Strong knowledge of GMP (Good Manufacturing Practices) and ISO 13485 standards, along with regulatory affairs. Strong creative, analytical, and problem-solving skills. Proficient in interpreting data and compiling detailed reports. Expertise in Design Quality, Good Manufacturing Practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, and Manufacturing Processes. Expertis

Sr. Principal Software Quality EngineerJob Title - Sr. Principal Software Quality Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Bellevue, Washington, USA

Full-time

Responsibilities: Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development Framework (SPDF) and software security best practices. Support Agile software development teams, ensuring regulatory and quality compli

Mechanical Engineer with Medical DeviceJob Title - Mechanical Engineer with Medical Device

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Roles & Responsibilities: Mechanical Engineering Degree. Quality Control exposure. ISO 13485 awareness (not mandatory). College Graduate (s) to (less than) 10 years of experience. Experience with relevant Supplier Quality requirements is added advantage. Management of supplier Quality lifecycle Support. Engineering documents Pre-review Support. Supplier NC/CAPA lifecycle Management Support. Quality Agreement update Support. Weekly/Monthly Project progress dashboard generations. Procedures/SOPs u

Manager, Regulatory ComplianceJob Title - Manager, Regulatory Compliance

CleerlyCompany Name - Cleerly

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New York, New York, USA

Full-time

About the Opportunity We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Manager, Compliance must be a subject matter expert in compliance, encompassing domestic and international regulatory, quality, and related requirements. Responsible for proactively monitoring all relevant compliance changes and guiding the company to maintain adherence and achieve strategic success.. You'll be joining a

Application Developer IIIJob Title - Application Developer III

Boston Scientific CorporationCompany Name - 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

Staff Engineer Distribution Quality (Hybrid)Job Title - Staff Engineer Distribution Quality (Hybrid)

Becton Dickinson & CompanyCompany Name - Becton Dickinson & Company

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Remote or Covington, Georgia, USA

Full-time

Job Description Summary As a Quality Engineer at our Distribution Center, you will be instrumental in upholding the highest standards of regulatory compliance and product quality. Your role is critical in maintaining operational excellence, with a strong focus on the quality engineering processes specific to the distribution of medical devices and pharmaceuticals. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing

Senior Reliability EngineerJob Title - Senior Reliability Engineer

GE HealthcareCompany Name - GE Healthcare

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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 EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

EngineerJob Title - Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Sr. Firmware EngineerJob Title - Sr. Firmware Engineer

JobotCompany Name - Jobot

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Colony, 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. Firmware EngineerJob Title - Sr. Firmware Engineer

JobotCompany Name - Jobot

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Bonner Springs, Kansas, USA

Full-time

Sr. Firmware EngineerJob Title - Sr. Firmware Engineer

JobotCompany Name - Jobot

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Overland Park, Kansas, USA

Full-time

Sr. Firmware EngineerJob Title - Sr. Firmware Engineer

JobotCompany Name - Jobot

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Bucyrus, Kansas, USA

Full-time

Senior Engineer, QualityJob Title - Senior Engineer, Quality

ICU Medical, Inc.Company Name - ICU Medical, Inc.

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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

EMS Validation Engineering LeadJob Title - EMS Validation Engineering Lead

Schneider ElectricCompany Name - Schneider Electric

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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