- 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …compliance, or a related field within the healthcare industry and experience in SaMD ( Software as a Medical Device ). + Proven track record in developing ... Solutions team , you will report to Head of Patient Digital Solutions & SaMD Service Line-Data, Digital & Technology and work with key stakeholders. **How you will… 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
- Medtronic (FL)
- …security requirements. **A Day in the Life** The audit focus will be primarily medical device software , product security, and risk management. We look ... Software and Product Security to identify gaps in medical device software .** + **Provide...devices + Experience in Quality/Compliance and/or Audit with medical device requirements (eg, MDSAP, EU MDR,… more
- Abbott (Plano, TX)
- …a software -focused company or company with software as a medical device ( SAMD ). Apply Now (https://www.jobs.abbott/us/en) * Participants who complete ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....and strategic input to product development teams for product software (embedded and mobile, medical and non-… 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
- Fresenius Medical Center (Lawrence, MA)
- …regulatory requirements and standards as they pertain to the development and release of medical devices . . Assist with various projects as assigned by a direct ... SaMD product development . IEC 82304 - Health Software . Understanding of how Agile Software ...and data privacy **Experience** . 2+ years of relevant experience in medical device cybersecurity and data… more
- Medtronic (Lafayette, CO)
- …classes (US FDA classifications - Class I, II, III), Software as a Medical Device ( SaMD ), Combination Products, and/or HCT/P products. + Experience ... In this exciting role, a day in the life as a senior leader in medical device quality systems can be quite varied and dynamic. You will be responsible for… more
- Philips (Chicago, IL)
- … devices globally. + You have experience with Software as Medical Device ( SaMD ), and Ultrasound Imaging Devices (preferred). + You have a strong ... fit if:** + You've acquired a minimum of 7 years' experience in FDA regulated Medical Device Regulatory Affairs, with proven expertise in US FDA 510K, China… more
- Medtronic (Minneapolis, MN)
- …and/or HL7 Certifications + Building software classified as Software as a Medical Device ( SaMD ) + Understanding of EHR technologies such as EPIC, ... Qualifications) + Strongly Preferred: + Previous Medtronic experience + Previous Healthcare or Medical Device experience + iOS Development + Proficient in Swift… more
- Medtronic (New York, NY)
- …all functional areas + Demonstrated business planning and forecasting excellence + Medical device /equipment sales experience. + Experience selling to physicians ... to Have** + Enterprise level technical sales, with life science, healthcare, or software (SaaS, PaaS, SaMD ) background strongly preferred + Proven consistent… more