- Abbott (Burlington, MA)
- …health and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance ... oversight for Software Development projects. The **_Staff Software Quality Engineer_** is responsible for executing...FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and… more
- Fresenius Medical Center (Lawrence, MA)
- …Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation or ... as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning...experience in software engineering, information technology, or software quality assurance in a regulated environment;… more
- Wolters Kluwer (Waltham, MA)
- …compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities focused on 21 CFR 820, ISO ... testing activities, including verification and validation. + Lead resolution of quality issues with on-market device software ; drive investigations related… more
- Philips (Cambridge, MA)
- …regulatory and quality standards. **Your role:** + Lead clinical imaging software architecture with a balance of immediate delivery goals and future technical ... managing technical debt and prioritizing customer-centric non-functional requirements. + Ensure software compliance with medical regulatory standards like FDA ,… more
- Philips (Cambridge, MA)
- **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The Director, Regulatory Affairs-SW and AI will lead the regulatory strategy of ... all Software /Artificial Intelligence platforms for the Ultrasound business. **Your role:**...proactive, strategic relationships with external stakeholders (notified Bodies, US FDA , Competent Authorities, etc.) to ensure that requirements are… 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. ... Collaborate with cross-functional teams, including hardware engineers, product managers, and quality assurance, to define software requirements and deliver high-… more
- General Motors (Boston, MA)
- … Engineer at General Motors should be an experienced leader who cares deeply about software and software quality . As a Principal Software Engineer, ... Electrical Engineering, or related degree + 10+ years of experience in Embedded Software development and launching quality software into production +… more
- Globus Medical, Inc. (Methuen, MA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... can resume their lives as quickly as possible. **Position Summary:** The Senior Software Engineer will be responsible for major software development modules for… more
- J&J Family of Companies (Danvers, MA)
- …Function:** R&D Product Development **Job Sub** **Function:** R&D Software /Systems Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** ... Hill Dr **Job Description:** Johnson & Johnson is currently seeking a Sr. Embedded Software Engineer to join our R&D Engineering team located in Danvers, MA. At… more
- Philips (Cambridge, MA)
- …full ability to scale. **Your role:** + Design, develop, deploy, and release software applications in an FDA -regulated environment for a startup-like medical ... **R&D Application Software Engineer - C++ & Python for Medical...won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the… more
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