- Abbott (Alameda, CA)
- …products that meet budgetary objectives. + Implement approved design control procedures for software development in accordance with FDA guidelines. + Lead ... monitor their glucose levels with our new sensing technology. This Embedded Software Engineer works independently on the design, development, and maintenance of… more
- Abbott (Columbus, OH)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Experienced in ... the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with...concerns in a timely manner + Comply to all FDA policies and standards + Use M-Files to house… more
- Stryker (Portage, MI)
- …accordance with internal software development lifecycle requirements in compliance with FDA software development guidance. + Supports the research and design ... hardware using oscilloscopes, logic analyzers, and other hardware tools. ** Software Engineering/Computer Science Majors:** + Support development of procedures and… more
- Bristol Myers Squibb (Seattle, WA)
- …systems (LIMS) or bioinformatics platforms. + Familiarity with regulatory standards for medical software (GMP, GxP, FDA , IEC 62304). + Experience in test-driven ... **Position Overview:** We are seeking a motivated and innovative Software Development Engineer (SDE) to join our cell therapy...reviews, and adherence to regulatory standards (eg, GMP, GxP, FDA , IEC 62304) as applicable. + Troubleshoot, debug, and… more
- Medtronic (Newton, MA)
- …components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, FDA regulations) is preferred but not required. ... Medtronic is seeking a highly skilled and experienced Senior Software Engineer to join our Affera Mapping and Ablation...Engineer to join our Affera Mapping and Ablation System Software Team. This role is pivotal in designing and… more
- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX, USA) ... Type:Regular Workplace Type:Remote or Hybrid or Onsite Apply Now (https://dow.wd1.myworkdayjobs.com/ExternalCareers/job/Midland-MI-USA/ FDA -Product-Regulatory-Manager\_R2060938/apply) Return to Job Finder At Dow, we believe… more
- Cordis (Irvine, CA)
- …under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation activities **Qualifications** + 7+ years as ... a Business Analyst, Functional Consultant, or Systems Analyst in a manufacturing setting. + Bachelor's degree in industrial engineering, information systems, or similar discipline; or equivalent experience. + Hands-on expertise with JD Edwards EnterpriseOne… more
- Abbott (San Diego, CA)
- …millions of people. This role oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They ... development activities under guidance and mentoring junior engineers. Adherence to FDA -compliant Design Control procedures and proficiency in software … more
- Abbott (Alameda, CA)
- …Embedded Software Engineer oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They ... development activities under guidance and mentoring junior engineers. Adherence to FDA -compliant Design Control procedures and proficiency in software … more
- Abbott (Santa Clara, CA)
- …and demonstrated experience with US submissions and a solid knowledge of FDA regulations + Strong understanding of software lifecycle management, including ... regulated environments. + In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485, GDPR) relevant to software... FDA , EMA, ISO 13485, GDPR) relevant to software products, especially in healthcare and medical devices. +… more