- Intertek (Boxborough, MA)
- Project Engineer - Medical Device Testing, Boxborough, MA Intertek, a Nationally Recognized Testing Lab (NRTL) and leading provider of quality and safety ... the top recognized brands and companies is actively seeking a Project Engineer - Medical Device Testing to join our Electrical team in Boxborough, MA.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …support lifecycle management of commercial combination product. The Staff Device Engineer has extensive experience in medical devices for drug delivery ... of my knowledge. **Job Description** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for...with medical device and combination device regulations. + Lead project execution activities… 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 all ... **Position Overview** The LEAD PROJECT TEAM SUPPORT ENGINEER -MI provides remote...manages. + Maintains an expert working knowledge of current medical imaging products and related technologies. + May be… 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 all ... **Position Overview** The HL7 Integration Engineer (IE) for Canadian region oversees all technical...must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical… more
- Medtronic (Boston, MA)
- …implementation, build, test, deployment and debugging of embedded software on a medical device + Architecting, implementing, and supporting an end-to-end CI/CD ... office in the Seaport District of Boston, MA, as a Principal DevOps Software Engineer you will lead and/or participate in supporting our CI/CD infrastructure for the… 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 all ... **Position Overview** The Senior Upgrade Engineer is responsible for performing upgrades for Fujifilm...for performing upgrades for Fujifilm Healthcare Americas Corporation (HCUS) Medical Informatics (MI) products to all eligible sites. In… more
- Hologic (Marlborough, MA)
- …Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software? Hologic is seeking a **Lead Software Design ... Lead Software Design Assurance Engineer Marlborough, MA, United States Newark, DE, United...excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD).… more
- Hologic (Marlborough, MA)
- …Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a **Lead Design ... Lead Design Assurance Engineer Newark, DE, United States Marlborough, MA, United...to hear from you! **Knowledge:** + In-depth understanding of medical device regulations and standards, including ISO… more
- Celestica (Boston, MA)
- …Celestica product design partners. + Understanding ISO 13485 requirements for medical device engineering changes. **Knowledge/Skills/Competencies** + An "out of ... and key characteristics that allow for substitution. + Understanding of IEC 60601-1 Electrical Medical Device Safety Standard. + Understanding of ISO 13485 as it… more
- Medtronic (Boston, MA)
- …with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring ... Experience in Quality Assurance, Engineering, Capital equipment + **Industry Experience:** Medical device industry. + **Technical Skills:** Proficient in quality… more
- Integra LifeSciences (Mansfield, MA)
- …or Science (Biology, Chemistry). * 8 years of experience of working within a Medical device or other regulated industry with knowledge of Risk Management (ISO ... of care. This **Staff Design & Reliability Assurance Quality Engineer ** is a key functional role within the Design...14971 2019), MDD ( Medical Device Directive), IEC 62366, ISO 13485… more
- Hologic (Marlborough, MA)
- …& Attributes:** + Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP. + ... Post Market Quality Engineer Newark, DE, United States Marlborough, MA, United...quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic's Breast and Skeletal Health Division… more
- Olympus Corporation of the Americas (Westborough, MA)
- …matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC ... product delivery while maintaining compliance and quality. + Provide project management oversight for QMS integration, Quality plans, process...+ Minimum of 6 years of experience in a medical device setting. + Experience in the… more
- Hologic (Marlborough, MA)
- …teams in the execution of design changes, product enhancements, and quality projects for medical device products. This position plays a vital role in ensuring ... experience, with a preference for 3 years in a medical device process and/or product development environment....Medical Devices Directive. + Effective team leadership and project management skills. + Strong knowledge of root cause… more
- Hologic (Marlborough, MA)
- …field required; Master's preferred. + Extensive understanding of engineering principles, medical device development, and customer-centric design. + Advanced ... Sr. New Product Development Engineer - Marlborough, MA Marlborough, MA, United States...in documentation and deliverables. **Experience** + 5+ years in medical device product development with a Bachelor's… more
- Jacobs (Boston, MA)
- …and as-built processes; verify construction install with model based practices; create project processes and lead mobile device trainings for field employees; ... are seeking an experienced Virtual Design & Construction (VDC) Engineer to manage and optimize our digital delivery processes...and client goals and define digital delivery scope for project estimates, and coordinate project technical setup… more
- Actalent (Newton, MA)
- …and establish best practices for electrical engineering development within a regulated medical device environment. Responsibilities + Lead and resolve complex ... Job Title: Principal Electrical Engineer Job Description Join our innovative R&D organization...document, and maintain detailed processes and best practices for medical electronics development. + Design, document, and execute electronic… more
- Hologic (Marlborough, MA)
- …+ In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory ... Principal Quality Assurance Engineer Marlborough, MA, United States Louisville, CO, United...and compliance. **Experience:** + Minimum 12+ years in the medical device industry. + Proven track record… more
- ManpowerGroup (Newton, MA)
- …projects from prototype through verification, ensuring compliance within a regulated medical device environment. This role offers an exciting opportunity ... passionate about improving procedural control, precision, and workflow in medical interventions. **Job Title:** Senior Development Engineer **Location:**… more
- Fresenius Medical Center (Waltham, MA)
- …cache (eg Redis) + Experience working in a highly regulated industry, medical device preferred. + Experience and knowledge of cybersecurity methodologies ... the design, development, testing, and/or support of web-based software for NxStage Medical 's products. **Specific Duties:** + Design, develop, code and unit test… more