- 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
- J&J Family of Companies (Santa Clara, CA)
- …organizational, problem solving, and analytical skills + Working knowledge of IEC 62304, FDA 's General Principles of Software validation, ISO 13485, ISO 14971, ... **Job Function:** R&D Product Development **Job Sub** **Function:** R&D Software /Systems Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:**… 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
- Abbott (Casa Grande, AZ)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. **In compliance ... of millions worldwide. You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **What You'll Work On:** +… 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
- 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
- General Dynamics Information Technology (Silver Spring, MD)
- …Obtain:** None **Public Trust/Other Required:** MBI (T2) **Job Family:** Software Engineering **Skills:** Agile Methodology,Atlassian JIRA,Scrum **Experience:** 10 + ... Master Advisor** to support the **Food and Drug Administration ( FDA )** and their critical mission needs. As a Scrum...implementing the Scaled Agile Framework (SAFe). + Experience with software development or working in software development… 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
- ManpowerGroup (Maple Grove, MN)
- …of regulatory and compliance requirements specific to healthcare and medical device software (eg, FDA , ISO 13485, IEC 62304). Key Responsibilities * ... Department:** R&D Software Development **Location:** Maple Grove **Job Type:** Full-Time/...IEC 62304, ISO 13485, 21 CFR Part 11, and FDA Design Controls. * Solid understanding of Agile, Scrum,… more