- Takeda Pharmaceuticals (Lexington, MA)
- …sound technical recommendations to move projects forward. + Identify, communicate and lead device design control process evolution to meet device ... registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device... design control deliverables to comply with medical device and combination device regulations. + Lead… more
- Takeda Pharmaceuticals (Lexington, MA)
- …products, digital health technologies across multiple therapeutic areas + Experience with device design control processes and risk management methodologies + ... programs for clinical research sites + Provide real-time clinical guidance on device -related aspects during trials ** Design Control Adherence:** + Ensure… more
- Sanofi Group (Cambridge, MA)
- …**Technical Knowledge:** Understanding of clinical development of medicinal products, device (including design controls), manufacturing processes, and regulatory ... **Job Title:** GRA Device Lead (Associate Director) - Digital Health **Location:**...enable successful regulatory outcomes. + Prepare, review and approve design control deliverables. + Contribute to product development and… more
- Hologic (Marlborough, MA)
- …visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director of ... Degree. + Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device... Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO 14970, IEC 60601,… more
- Takeda Pharmaceuticals (Boston, MA)
- …into the product portfolio to drive operational excellence and innovation in CMC and device design + Ensure all products are developed and maintained in ... best of my knowledge. **Job Description** **_Objective / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy across… more
- Abbott (Burlington, MA)
- …or Burlington, MA location in the Abbott Heart Failure Division Global Design Quality Department. In Abbott's Heart Failure (HF) business, we're developing solutions ... lives. We are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are developed...13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical … more
- Takeda Pharmaceuticals (Boston, MA)
- …a team lead in a matrix environment relating to combination products and device manufacturing. + Strong understanding of design control and regulatory ... my knowledge. **Job Description** **Title: Senior Manager, Combination Products and Device Manufacturing** **Location: Cambridge, MA** **About the role:** As a… more
- US Tech Solutions (Marlborough, MA)
- …platform for developing interactive E-modules + Someone from healthcare, pharma, medical device environment + Instructional design . Must be able to walk ... process/demonstrating experience (Addie model understanding. **Key responsibilities:** + Instructional Design : design and develop high-quality learning materials… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry. + OR, Master's degree and ... Human Factors Engineering, Biomedical Engineering, Industrial Engineering, other relevant degrees in device design or biotech industry. + OR, Bachelor's degree… more
- Amgen (Cambridge, MA)
- …variety of challenging problems associated with advanced material modelling, device design , characterization, verification, validation, manufacturing and ... + Experience with combination products and device regulatory requirements, medical device development and design controls, and knowledge of process controls.… more