- Integra LifeSciences (Mansfield, MA)
- …position will provide technical expertise and project management in the areas of medical device manufacturing process development and validation, DFM, COGs ... possible and making headway to help improve outcomes. The Senior Manufacturing Engineer I will work within...broad knowledge of manufacturing processes applicable to medical device manufacturing is required.… more
- Hologic (Marlborough, MA)
- …a strong understanding of applicable regulations, such as but not limited to, the Medical Device Regulations, IVD Regulation, QSR, ISO 13485, ISO 14971, MDSAP, ... MA, United States San Diego, CA, United States **Position Title:** Senior Director of Manufacturing Quality **Locations:** Newark, Delaware, Marlborough,… more
- Hologic (Marlborough, MA)
- …10 years' experience of running multiple plants and contract manufacturers. + Medical Device experience is preferred. + Established leadership experience in ... President of Manufacturing Operations** **Position Title:** Vice President of Manufacturing Operations **Reports To:** Senior Vice President, Global Supply… more
- Sanofi Group (Cambridge, MA)
- …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... Senior Design Engineer operates within and contributes across ALL medical device lifecycles including early-stage innovation, Design/Development Programs as… more
- Amgen (Cambridge, MA)
- … medical devices (Class II and Class III) + Solid experience in medical device manufacturing and development processes, including experience working under ... transform the lives of patients while transforming your career. Senior Engineer, Design Transfer Specialist **What you will do**... sites. This role requires a deep understanding of medical device design, manufacturing processes,… more
- Amgen (Cambridge, MA)
- …7+ years of relevant work experience with 5+ years of experience in operations/ manufacturing environment. + Medical device industry experience and regulated ... products. This includes technical operations support for design control activities, device manufacturing , failure investigations, leading and assessing design… more
- Amgen (Cambridge, MA)
- …for overseeing the injection molding processes, ensuring the production of high-quality medical device components from our manufacturing sites. This ... transform the lives of patients while transforming your career. Senior Engineer, Injection Molding Expert **What you will do**...experience as an engineer or scientist in relevant fields ( medical device development, manufacturing , etc.)… more
- J&J Family of Companies (Boston, MA)
- …testing, and validation of digital, navigation, and robotic technology for the orthopedic medical device industry that meet the highest standards of safety, ... Description:** Johnson & Johnson Medtech Orthopaedics is recruiting a Senior Director of Systems Engineering and Testing to join...with a strong background in both conceptual design and medical device product development. She/he will be… more
- FST Technical Services (Boston, MA)
- …and laboratory environments while interfacing with exciting clients in the pharmaceutical, medical device , microelectronics, semi-conductor and medical ... on commissioning and consulting projects within a variety of manufacturing environments. For this position of Senior ...of manufacturing environments. For this position of Senior Commissioning Engineer on offer includes an excellent salary… more
- Hologic (Boston, MA)
- …skills and a deep understanding of supply chain dynamics, particularly in the medical device industry and influencing across functions. The ideal candidate will ... Senior Manager, Supply and Demand Planning San Diego,...demand planning, or a related field, preferably in the medical device industry. + Proven leadership experience… more
- Integra LifeSciences (Boston, MA)
- …training programs to enhance the skills and competencies of employees in a medical device -regulated environment. The Senior Training Specialist will assess ... patient outcomes and set new standards of care. The Senior Quality Compliance Specialist -Training will create and conduct...field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent… more
- Integra LifeSciences (Braintree, MA)
- …teams, quality teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA Supplements,361 HCT/Ps, ... and international dossier submissions; Experience with medical device , biologic or implantable products is preferred, but not required. + Understanding and… more
- Integra LifeSciences (Mansfield, MA)
- …a scientific discipline required with minimum of 5 years' experience in the medical device or pharmaceutical industry. Years of experience and education ... pathways to advance patient outcomes and set new standards of care. The Senior Quality Engineer I is responsible for supporting the site Quality Management System… more
- Integra LifeSciences (Boston, MA)
- …or related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing , or equivalent education and ... treatment pathways to advance patient outcomes and set new standards of care. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is responsible for… more
- Olympus Corporation of the Americas (Westborough, MA)
- …other relative experience. + Minimum 5 years prior regulatory affairs experience in the medical device industry. Working knowledge of medical device ... live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care...Participate in functional improvement projects. + Provide reports to senior management regarding the status of key deliverables. +… more
- Philips (Cambridge, MA)
- The Senior Quality Engineer- Products and Systems is a...CFR Part 803, 806 & 820) and knowledge of medical device process requirements. + You have ... problem solving and root cause analysis during design and manufacturing and initiates field actions when required. + Supports...extensive experience and expertise with medical device design controls, product risk files,… more
- ConvaTec (Lexington, MA)
- …8+ years of experience successfully managing and delivering strategic projects for a medical device company + Project management qualification is preferred (PMP ... Pioneering trusted medical solutions to improve the lives we touch:...learn more about Convatec, please visit http://www.convatecgroup.com Our successful Senior Project Manager of Strategic Initiatives will oversee the… more
- Stryker (Boston, MA)
- …and ability to lead teams in implementing FDA, GMP, ISO, and other medical device regulatory requirements. + High degree of expertise with biocompatibility ... ** Senior Manager - Biocompatibility and Toxicology (Remote)** Stryker...with cross-functional project teams to define evaluation/verification strategies of medical devices. + Identify new/emerging regulatory requirements and customer… more
- Integra LifeSciences (Braintree, MA)
- …education and years of experience + 4+ years of experience in a laboratory or manufacturing engineering in a medical device or pharmaceutical environment. + ... what's possible and making headway to help improve outcomes. The Senior Laboratory Process Improvement Specialist will partner with Integra's internal operational… more
- Hologic (Marlborough, MA)
- …detailed reports on recall activities and outcomes. + Ensure timely submission of Medical Device Reports (MDR) and Vigilance Reports to regulatory bodies and ... to the FDA Quality Management System Regulation (QMSR), In-vitro Diagnostic Regulations (IVDR), Medical Device Single Audit Program (MDSAP), ISO 14971, and ISO… more