- Amgen (Cambridge, MA)
- … (ISO 13485); + Risk Management (ISO 14971); + EU Medical Device requirements (Council Directive 93/42/EEC); + Medical Electrical Equipment (EN ... various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key… more
- Fujifilm (Boston, MA)
- …to be an integral part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas Corporation and FUJIFILM SonoSite, ... working independently and collaboratively on legal issues affecting the Medical Device businesses to minimize risks of...large volume of contracts, to ensure agreements mitigate legal risk and support business objectives. + Advise, counsel and… more
- Takeda Pharmaceuticals (Lexington, MA)
- … and combination product development programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing ... clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** ** Device Clinical Strategy & Risk Management :** +… more
- Sanofi Group (Cambridge, MA)
- …The GRA Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic products within the ... phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery… 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 software development sector. In this critical role, you will be responsible for… more
- Beth Israel Lahey Health (Burlington, MA)
- …**Job Description:** Will have in depth knowledge of cardiac rhythm management , cardiac devices, and cardiovascular physiology. Provides in-clinic testing and ... judgment of when to perform basic reprogramming of the device based on the analysis, done within the scope...possess judgment to direct to the Arrhythmia Service Providers. Management and analysis of data in the electronic database,… more
- Eliassen Group (Westborough, MA)
- …Description + Recommended Jobs **Description:** *Hybrid in Westborough, MA* Our Fortune 500 medical device client is seeking a **Sr. Principal R&D Engineer** to ... expectations. They will evaluate trade-offs in cost, time, and risk to make sound, long-term decisions, applying deep expertise...to make sound, long-term decisions, applying deep expertise in medical device design control to guide projects… more
- Philips (Cambridge, MA)
- …on budget. + Your skills include product quality and reliability metrics, risk management , and FMEA in medical device regulated environment. + You have ... of professional experience with leading complex new product development projects in medical device regulated environment and proven track record of delivering… more
- Medtronic (Boston, MA)
- …the organization. As a senior member of the team, you will provide expertise in risk management , compliance, and security strategy, while also playing a key role ... + Maintain up-to-date knowledge of cybersecurity regulations and standards specific to the medical device industry (FDA, HIPAA, IEC 62443, NIST, NIS 2, etc.).… more
- Philips (Cambridge, MA)
- …working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards. + You have experience ... the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design...years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus… more