- US Tech Solutions (San Bruno, CA)
- …in software development for medical devices , specifically focusing on Software as a Medical Device ( SaMD ) or low-risk enforcement discretion ... CAPA, complaints, audits, and overall QMS functions. **Mandatory:** + Medical Device Software Experience: +...strictly on software quality engineering in a software -only context. **Skills:** + QMS + SaMD … more
- Precise Solutions (Lake County, IL)
- …Description: Primarily responsible for representing QA on cross-functional Software as a medical device ( SaMD ) and Digital Health Software product ... QA activities related to Software as a Medical Device ( SaMD ) and Digital... Medical devices , specifically development of Software Medical Devices is desired.… more
- Teleflex (Mansfield, MA)
- …remediation of design history files/technical files. * Experienced in Software as a Medical Device ( SaMD ) and software validation. * Working ... is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades… more
- AbbVie (North Chicago, IL)
- …County, IL Primarily responsible for representing QA on cross-functional Software as a medical device ( SaMD ) and Digital Health Software product ... QA activities related to Software as a Medical Device ( SaMD ) and Digital...+ * Strong understanding of regulations and standards affecting software medical devices such as… more
- Meta (Seattle, WA)
- …have deep domain experience in electromechanical devices and software as a medical device ( SaMD ). **Required Skills:** Head of Medical Devices ... regulators in particular for Software as a Medical Device ( SaMD ) products 11....of regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD… more
- US Tech Solutions (San Bruno, CA)
- …+ Experience in Medical Device Manufacturing or Software as a Medical Device ( SaMD ). + Experience with Quality Management Systems (QMS). + 3+ ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...audit readiness and regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more
- Abbott (Burlington, MA)
- …Prior experience in a software -focused company or company with software as a medical device ( SAMD ). The base pay for this position is $144,100.00 - ... of FDA regulations and guidance, ISO 13485, Software Standards (eg, IEC 62304), EU Medical Device Regulations, and MDSAP **Preferred Qualifications**… more
- Medtronic (Los Angeles, CA)
- …the Medical Devices Directive (93/42/EEC) and European Medical Device Regulation 2017/745 + **Experience with SaMD and Digital Health apps** + ... global regulations. This role focuses on products with hardware, ** SaMD / Digital Health apps** , and/or interoperability with...(EU MDR), and other international geographies. + Experience with medical device software requirements and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is at the forefront of developing and implementing Software as a Medical Device ( SaMD ) strategies, overseeing product platforms, and ensuring compliance ... tools for evidence generation. + Drive the development and deployment of SaMD products, focusing on strategic platform integration and lifecycle management. +… more
- Medtronic (Los Angeles, CA)
- …+ Experience with technical presentations and/or education sessions + Product experience with software medical devices and quality systems + Good working ... for those with experience in other areas of the medical device space who are looking to...to evolve their careers, including those with backgrounds in device advocacy, systems engineering, software design, cybersecurity,… more