- 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
- 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
- Abbott (Alameda, CA)
- …software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control procedures for software development. + Demonstrate ... independently under limited supervision, performs highly complex and specialized level software project activities in such areas as Development, Tools, Test,… more
- Philips (San Diego, CA)
- …the right fit if:** + You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on ... The Sr. Manager- Software Design Assurance will play a critical role...Assurance will play a critical role in managing/supporting the Software Design Control process for new/existing Image Guide Therapy… more
- Actalent (Valencia, CA)
- …such as medical devices, aerospace, or automotive. + Familiarity with IEC, FDA premarket cybersecurity guidance, or other relevant software lifecycle and ... Software Engineer Job Description We are seeking a versatile and motivated Software Engineer to join our growing team. This role offers the opportunity to work… more
- Medtronic (Irvine, CA)
- …antikickback, antitrust, False Claims Act, HIPAA, state data privacy and security laws, software licensing, FDA law, IP and other legal risk areas governing ... data-enabled healthcare technology and AI commercial transactions. + Develop, review, or implement company-wide and/or functionally specific training programs for the areas described above. + Monitor evolving regulatory standards impacting commercial… 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