- Takeda Pharmaceuticals (Lexington, MA)
- …+ Provide senior-level Quality leadership and guidance across design, development , technology transfer, commercialization, and post- market surveillance. + ... all business units, geographies, and therapeutic modalities spanning Takeda's development pipeline and lifecycle management of marketed products. Drive...FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR /IVDR, MDSAP). + Act as or designate the Device… more
- Medtronic (Newton, MA)
- …of cybersecurity and the software lifecycle within regulated environments, including design, development , and post- market support. + Experience with cardiac and ... a team of engineers and cross-functional partners to support design, development , and maintenance of software for Affera cardiac electrophysiology systems. By… more
- Medtronic (Boston, MA)
- …software. Contribute to OU and enterprise-wide product security strategy and roadmap development . + **Secure Product Development Lifecycle** - Drive security ... into embedded systems or connected medical devices in a regulated product development environment + Strong understanding of secure development lifecycle (SDLC),… more