- 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
- 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 Software Project Engineer will be responsible for major software modules for ... needs to have strong architectural and technical skills in software engineering. The position will be a hands-on one...individually or as a team + Understanding of an FDA design control environment + Contributing to designing, testing… 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. Fueled… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Description** We're looking for a Principal Software Engineer to join our growing team and lead the development and strategy for our Digital Medicine ... high-performance, scalable, data-centric, serverless microservices + Own and deliver software architecture, diagrams, design documents + Primary engineering lead,… more
- Eliassen Group (Boston, MA)
- ** Software Engineer** **Anywhere** **Type:** Contract-to-Hire **Category:** Development **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN ... Jobs **Description:** Our client is hiring for an iOS Software Engineer to join their team in San Diego,...PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation.… more