- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... products, digital health technologies across multiple therapeutic areas + Experience with device design control processes and risk management methodologies +… more
- Sanofi Group (Cambridge, MA)
- …with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development, manufacturing, quality , supply chain) and drug product ... team is a globally diverse team supporting the medical device , combination product, digital health and...standards and guidelines. The incumbent has a patient- and quality -focused mindset and drives a culture of continuous improvement… more
- Hologic (Marlborough, MA)
- …leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director ... Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical ...especially Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO… more
- Abbott (Burlington, MA)
- …the Global Design Quality Department, provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient ... MA location in the Abbott Heart Failure Division Global Design Quality Department . This is an...ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience… more
- Integra LifeSciences (Braintree, MA)
- …(Biomedical or Mechanical) or related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, ... and making headway to help improve outcomes. The Senior Quality Engineer I - Design & Reliability...collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs. Support Design Reviews, Technical Reviews,… more
- Integra LifeSciences (Braintree, MA)
- …(Biomedical or Mechanical) or related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, ... us are challenging what's possible and making headway to help improve outcomes. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for… more
- Amgen (Cambridge, MA)
- …various global manufacturing sites. This role requires a deep understanding of medical device design , manufacturing processes, and regulatory requirements. ... experience as an engineer or scientist in relevant fields ( medical device development, manufacturing, etc.) + Proven...to work within cross-functional and cross-cultural teams + Extensive device development competences within: + Design of… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... team is looking for a highly-motivated, energetic, technically driven Embedded Software Design Engineer to focus on the development of application level SW and… more
- Medtronic (Newton, MA)
- …the guidance of some of the industry's prominent experts in the field of medical device engineering while working in a fun and collaborative office environment. ... Ablation System** The Affera Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias. The system involves… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... team is looking for a highly-motivated, energetic, technically driven Sr. Embedded Software Design Engineer to focus on the development of driver level SW with a… more