- 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
- 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
- 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
- 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
- Hologic (Marlborough, MA)
- …with Bachelor's, 6+ years with Master's) in new product development within the medical device industry. + Deep clinical and technical knowledge in gynecological ... New Product Development (NPD) Engineer ** Are you passionate about driving innovation in medical devices? Join our team as a Lead NPD Engineer , where your… more
- AbbVie (Worcester, MA)
- …21 CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries. + Demonstrated problem solving skills and innovative ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- Hologic (Marlborough, MA)
- …particularly Design Control requirements. + In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity ... and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role,… more
- AbbVie (Worcester, MA)
- …21 CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries. + Demonstrated problem solving skills and innovative ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- Hologic (Marlborough, MA)
- …knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP. + ... Senior Post Market Quality Engineer Newark, DE, United States Marlborough, MA, United..., you will lead quality engineering efforts for on-market medical devices. This role is responsible for evaluating post-market… more