- 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, ... Learn more at https://www.jnj.com/medtech Johnson & Johnson is recruiting for a **Senior Software Quality Engineer** , located in Santa Clara, CA. Our team advances… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …external devices, ensuring robust communication and data handling. + Regulatory Compliance: Design software with FDA , QSR, and ISO quality system regulations in ... The Instrument Tech Transfer team develops new equipment, procedures, and test software for IVD medical device products that deliver rapid, high-impact, actionable… more
- Terumo Medical Corporation (Chicago, IL)
- …Align initiatives with PMO standards and regulatory requirements, including compliance for FDA Software as a Medical Device (SaMD) certification. Provide key ... to a broad range of constituents + Working knowledge of Epic and Cerner's software + Aptitude to identify and assimilate IT tools into the Care Pathway workflow… 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. + Proficient with ... supervisor You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures. **Required Qualifications** +… more
- Medtronic (Mounds View, MN)
- …+ **Audits & Compliance Readiness** - Support internal and external audits (eg, FDA , Notified Body, MDSAP), ensuring software quality documentation and evidence ... a more connected, compassionate world. **A Day in the Life** Senior Software Quality Engineer Careers that Change Lives Transforming hypertension treatment, Renal… 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
- 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
- Zimmer Biomet (Englewood, CO)
- …for connected orthopedic or wearable devices + Familiarity with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation + Experience with EU MDR ... primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware + Maintain expert knowledge of appropriate… more
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