- Medtronic (Boston, MA)
- …with medical devices and regulation - ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as medical devices, and IEC 62304. Experience performing ... role, you will join a world class team of mechanical, electrical and software engineers responsible for further development and enhancement of the globally launched… 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
- 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...Guided Therapies business. + Build, deploy, and maintain production software for ML and data pipelines. + Contribute to… more
- Medtronic (Boston, MA)
- …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
- 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 (Boston, MA)
- … teams, including hiring, performance management, and career development. + Experience in medical software regulation such as (ISO 13485, FDA 21 CFR Part 820). ... and technical excellence. + Lead Communities of Practice focused on software verification best practices, test automation strategies, and emerging technologies… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non-medical software...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
- Abbott (Burlington, MA)
- …+ Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with ... and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance with… more
- Globus Medical, Inc. (Methuen, MA)
- …can resume their lives as quickly as possible. **Position Summary:** The Senior Software Engineer will be responsible for major software development modules for ... Navigation & Robotics division. Having strong architectural and technical skills in software engineering, our Software Engineers are hands-on with creative and… more
- Medtronic (Boston, MA)
- …in a more connected, compassionate world. **A Day in the Life** As a Senior Software Test Engineer working in the Seaport District of Boston, MA, you will use your ... deep understanding of software verification techniques for medical or other regulated systems....to Have** + Experience with Medical Product verification and FDA guidance. + Basic understanding of creating test protocols… more