- 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
- US Tech Solutions (Waltham, MA)
- …to creating a stunning view and providing the physician with instant feedback. + The software test engineer will join a highly effective product quality team in ... in an Agile environment, developing test cases for a wide range of software components, including user interface, algorithms and back-end data handling. The position… more
- Globus Medical, Inc. (Methuen, MA)
- …testing methodologies and tools. + Collaborate closely with development teams to drive software quality and ensure traceability to requirements. + Lead peer ... maintain high quality standards. **Preferred Qualifications:** + 7+ years of software testing experience with a mix of manual and automated testing. + Background… 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
- Actalent (Newton, MA)
- …The ideal candidate will collaborate with cross-functional teams to deliver high- quality software solutions. Responsibilities + Conduct thorough manual testing ... quality assurance, to ensure the delivery of high- quality software . + Participate in continuous improvement...Understanding of regulatory requirements and standards for medical device software (eg, FDA , ISO). + Strong analytical… more
- Medtronic (Newton, MA)
- …product design engineers, software test, reliability, and leadership to define software requirements and deliver high- quality solutions. + Mentor and guide ... fostering a culture of innovation and excellence. + Apply best practices in software development to maintain high- quality code. + Attend and participate in… more
- Hologic (Marlborough, MA)
- …improve system performance, capacity, reliability, and scalability. Additionally, the ** Software Engineering Manager** will proactively manage project quality , ... + Minimum of 8 years of experience in the following areas: + Designing software products in an FDA -regulated industry, following IEC 62304 and ISO 14971… 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 ... patients can resume their lives as quickly as possible. **Position Summary:** The Senior Software Engineer will be responsible for major software modules for our… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …Utilize organizational process control systems and industry privacy requirements (ie, FDA quality controls, HIPAA) Required/Preferred Education and Experience + ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients… more
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