- 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
- Eliassen Group (Westborough, MA)
- …time, and risk to make sound, long-term decisions, applying deep expertise in medical device design control to guide projects through all stages of the product ... **Sr. Principal R&D Engineer, Med Device - Innovation Strategy** **Westborough, MA** **Type:** Contract-to-Hire **Category:** Research & Development **Industry:**… more
- Amgen (Cambridge, MA)
- …manufacturing sites. This role requires a deep understanding of medical device design , manufacturing processes, and regulatory requirements. Key ... to work within cross-functional and cross-cultural teams + Extensive device development competences within: + Design of...+ Extensive device development competences within: + Design of components for injection molding + Dimensioning 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
- Jabil (Clinton, MA)
- …within a medical device product development environment, command of medical device design controls and related regulatory requirements, a penchant for ... lifecycle to enable both the growth and maintenance of our medical device product portfolio. Primary responsibilities of the role include user needs assessment,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …sound technical recommendations to move projects forward. + Identify, communicate and lead device design control process evolution to meet device ... of design control elements to comply with combination produce/medical device regulations. Lead or assist in deviation, complaint and failure investigations. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …product security, cybersecurity, and equipment development oversight. Extensive knowledge of medical device design control requirements, system design and ... SOP's to ensure compliance. + Support the optimization of design control elements to comply with medical device... design control elements to comply with medical device regulations. + Implement product design with… 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
- J&J Family of Companies (Danvers, MA)
- …degree, or demonstrated ability with a Master's degree. + Thorough understanding of Medical Device Design Controls and Product Life cycle + Knowledge of FDA and ... plan and with little to no direct supervision. Prepare, present and lead design reviews to attain agreement on project with peers and multi-functional review team.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …make solid decisions with long-term impact. He or she must fully understand medical device design control requirements and be able to effectively guide a product ... strategies into product concepts, defining strategies for product specifications and design inputs, conceptual product design , and development/validation of… more