- Oracle (Augusta, ME)
- …and support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven ... **Responsibilities:** As a Principal Member of Technical Staff for Medical Device Software , your key responsibilities include: + Architectural… more
- ICS (Waltham, MA)
- Senior Project Manager - Medical Device Software Waltham, MA Apply Now Senior Project Manager, Medical Device Software Role SummaryWe are seeking ... a seasoned Senior Project Manager with extensive experience in the medical device / regulated software development sector. In this critical role, you will be… more
- Abbott (Burlington, MA)
- …EU Medical Device Regulations and MDSAP + Experience with medical device software development lifecycle for Cloud-based networks and/or mobile ... product software (Cloud Patient Care Networks, mobile applications and embedded software ), non- medical software , and non-product software + Support … more
- Capgemini (Waukesha, WI)
- As aC Linux Scripting Developer, you will be responsible for developing and maintaining medical device software applications that run on Linux systems. Your ... scalable. This role requires strong knowledge of Object-Oriented Analysis and Design, Software Design Patterns, and coding principles. **Your role** + Own, create… more
- Oracle (Little Rock, AR)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device … more
- Oracle (Helena, MT)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device … more
- Hologic (Newark, DE)
- Senior Software Engineer, Medical Device Newark, DE, United States Located in Newark, DE, **Hologic** 's Innovation Center is continuing to offer job ... opportunities. We are seeking a **Senior Software Engineer (C#/ .NET, Full Stack)** to design, develop,...secure coding principles or cybersecurity is a plus. + Medical device experience is a plus. +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, ... medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality… more
- US Tech Solutions (San Bruno, CA)
- …system issues. **Mandatory:** + 5+ years of experience in program management. + Experience in Medical Device Manufacturing or Software as a Medical ... screening. + The team develops and deploys hardware and software solutions to help screen for vision threatening eye...+ Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring… more
- Medtronic (Boulder, CO)
- …future generations live better, healthier lives. The audit focus will be primarily medical device software , product cybersecurity, and risk management. We ... subject matter expertise (SME), and technical knowledge working with regulated medical device software and product cybersecurity requirements. + Remain… more
- US Tech Solutions (San Bruno, CA)
- …frameworks, and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in ... experience in standalone software development, with a solid understanding of medical device software standards such as IEC 62304. ** Software Quality… more
- ZOLL Medical Corporation (Parsippany, NJ)
- …self-sufficiency Experience with Scrum is preferred, but not required + Experience with medical device software development is preferred, but not required ... technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat… more
- Bayer (Indianola, PA)
- … development processes, software architecture, data structure and compliance as it relates to medical device software and software as a medical ... product including Device Software Solutions, Class I and II Software as a Medical Device Applications; + Provide technical advice to the Cevego … more
- Fujifilm (Bothell, WA)
- …engineering practices and processesfor medical devices + Demonstrated experience developing medical device software compliant with IEC 62304 + Experience ... the resolutions meetperformance requirements andcustomer expectations. + Producesoftwarearchitecturedocumentationincompliance with medical device development standards. + Stay abreast… more
- Globus Medical, Inc. (Audubon, PA)
- …to the latest tools and methodologies in C++ development, robotics integration, and medical device software , with opportunities for continuous learning and ... and components for medical or robotic applications + Familiarity with medical device development, including regulatory and safety considerations, is highly… more
- Hologic (Newark, DE)
- …States Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software ? Hologic is seeking a **Lead Software ... meaningful impact on healthcare innovation. **Knowledge:** + Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820,… more
- Stryker (Redmond, WA)
- …code/vulnerability analysis and bug tracking tools. + Create efficient deployment processes for medical device software and ensure compliance with industry ... within the SDLC. + Familiar with regulatory and compliance standards relevant to medical device software , including IEC 62304, ISO 13485, and the FDA's… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …team of talented software engineers in the development and delivery of innovative medical device software solutions. This role is critical in driving ... + Proven experience managing software development teams in the medical device industry, with a strong understanding of regulatory requirements (eg, FDA 21… more
- Philips (San Diego, CA)
- …HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software . + Serving as SME for Software Design ... etc.) + 8+ years of experience in Software Quality and/or Software Development in medical device industry with hands on experience with SW Design… more
- Medtronic (Boston, MA)
- … verification best practices, test automation strategies, and emerging technologies relevant to medical device software . + Champion and implement Lean-Scaled ... Framework (SAFe) or other agile methodologies. + Prior experience with complex medical device software systems, particularly in robotics. + Experience in… more