- Dentsply Sirona (Waltham, MA)
- …software architectures. + Experience in leading technical teams. + Experience in MD ( Medical Device ) software a plus. Key Skills, Knowledge & ... and oral health products as well as other consumable medical devices under a strong portfolio of world class...worldwide. We are looking for an experienced and talented Software Architect to join our team. This individual will… more
- Fresenius Medical Center (Lawrence, MA)
- …Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure compliant products, engineering teams ... and actions derived **PRINCIPAL DUTIES AND RESPONSIBILITIES** . Works as part of software development team on new product development or on design changes to ensure… more
- Olympus Corporation of the Americas (Westborough, MA)
- …than 10 % **Preferred:** + MS in engineering or life sciences preferred. + Experience with medical device software , including software in a medical ... device (SiMD) and software as a medical device (SaMD), preferred. + Knowledge of regulatory submissions such as 510(k), De Novo, or CE marking for … more
- Sanofi Group (Cambridge, MA)
- …support a wide range of digital health technologies (DHTs), from digital biomarkers, wearables, software as a medical device (SaMD), connected devices and ... (GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products… more
- Medtronic (Boston, MA)
- …culture + **Compliance** - Ensure compliance with industry standards and regulations related to medical device and health software product security, such as ... in ensuring the security of Medtronic Surgical Operating Unit medical device solutions. Reporting to the Director...with the latest cybersecurity trends and threats specific to medical devices and health software products. Contribute… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Title: Senior Manager, Combination Products and Device Manufacturing** **Location: Cambridge, MA** **About the role:** As a ... Senior Manager, Combination Products and Device Manufacturing, you will manage and provide project and...Previous experience in injection molding, and proficiency in CAD/CAM software (eg, SolidWorks) is preferred. + Strategic enterprise thinking,… more
- Beth Israel Lahey Health (Burlington, MA)
- …for Cardiac patients with implantable devices, utilizing clinical and software application knowledge. Technical duties include pacemaker and cardiac defibrillator ... judgment of when to perform basic reprogramming of the device based on the analysis, done within the scope...updates data on assigned cardiac population, capturing data into software application and ensuring that follow up is current… more
- Lilly (Boston, MA)
- …and New Product Innovation Group within Lilly's DDCS (Delivery and Device Connected Solutions) function studies physiological barriers across various routes of ... patient centric drug delivery solutions. With a broad focus on developing injection device platforms and novel delivery devices to improve patient care, the group… more
- Capgemini (Waltham, MA)
- …+ Understanding of privacy regulations (HIPAA, GDPR) and their intersection with medical device cybersecurity. + Familiarity with Agile methodologies and ... the security testing of physical hardware, including embedded systems and connected medical devices. The ideal candidate will have hands-on experience working in… more
- Globus Medical, Inc. (Methuen, MA)
- …technical expertise in algorithms and software with leadership experience in regulated medical device environments and has a track record of delivering in ... Foster a culture of innovation, collaboration, and compliance with medical device standards. + Adhere to the...& Quality Compliance** + Ensure adherence to IEC 62304 ( medical software lifecycle), ISO 14971 (risk management),… more
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