- Takeda Pharmaceuticals (Lexington, MA)
- …design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with ... devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic… more
- Medtronic (Boston, MA)
- …or sales/service/engineering in the Cardiac Ablation, Cardiac Rhythm, or Implantable Medical Device Industry OR Advanced Degree in Engineering or ... sales/service/engineering in the Cardiac Ablation, Cardiac Rhythm, or Implantable Medical Device Industry Desired/Preferred qualifications: The successful… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and digital health solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies aligned with the ... Develop and maintain SOPs, compliance frameworks, and internal guidance tailored to non- medical device digital health initiatives. Design and deliver regular… more
- Edwards Lifesciences (Boston, MA)
- …productive internal/external working relationships The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will… more
- RTX Corporation (Andover, MA)
- …with device -level reliability testing and characterization in compound semiconductor field , preferably GaN and GaAs Experience in the design and execution of ... secure world. Job Summary An exciting opportunity has opened for a Senior GaN Reliability Engineer to join our Advanced Microelectronic Solutions Department (AMSD)… more
- Fujifilm (Boston, MA)
- …Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... Position Overview The Senior Upgrade Engineer is responsible for performing upgrades...for performing upgrades for Fujifilm Healthcare Americas Corporation (HCUS) Medical Informatics (MI) products to all eligible sites. In… more
- Olympus Corporation of the Americas (Westborough, MA)
- …teams, the RA Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, ... WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY Workplace Flexibility: Field For more than 100 years, Olympus has focused...of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of… more
- J&J Family of Companies (Danvers, MA)
- …in external manufacturing processes Skills including, but not limited to, Supplier Management, Medical Device Manufacturing, Global Medical Device ... Medical Equipment Manufacturing, Project Management, Supplier Management Preferred Skills: Medical Device Compliance, Medical Device Manufacturing… more
- J&J Family of Companies (Danvers, MA)
- …or related field . Experience: 10+ years in embedded software development in medical device domain. 4+ years in a leadership or managerial role. Proven ... Master, or equivalent project management certifications. Domain-specific certifications (eg, medical device software compliance, automotive safety standards).… more
- Takeda Pharmaceuticals (Boston, MA)
- …(MES, ERP,MODA, LIMS). Knowledge management product (PLM, R&D Search). Drug and Device Management Lab Validation. Structure and resource product teams based on ... a product-driven agile culture to support delivery excellence Collaborate with senior leaders across PharmSci, Research and RDDT including Business Partners, Tech… more
