- Olympus Corporation of the Americas (Westborough, MA)
- …The Staff Systems Engineer is a subject matter expert (SME) and provides project and engineering leadership in all phases of complex med-device development, as well ... and issues to all levels of the organization. **Job Duties** + Provide project and technical leadership as it relates to Systems to cross functional teams… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of America (OSTA) organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration ... will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure… more
- State of Massachusetts (Boston, MA)
- …informatics described and serves as the senior scientific and Laboratory manager responsible for the SPHL's strategic direction for its Laboratory Information ... by CLIA, A2LA for ISO17025: Food and Drug Administration ( FDA ); Department of Environmental Protection (DEP) and other Federal...least two (2) years must have been in a project management, supervisory or managerial capacity or (C) any… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …monitors, ventilators) in a matrix setting. Essential Functions + Works with project /program management and product management to establish and refine system level ... with assigned programs. + Under auspices of the program manager , leads efforts to allocate system functionality among electronic/software/mechanical subsystems,… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... expectations, and anticipating possible barriers or obstacles that may impact the project (s) adversely and communicating these on a timely manner. + Guarantee top… more
- Medtronic (Boston, MA)
- …minimum of 5 years of relevant experience. Experience as a Product Owner or Product Manager of at least 3 years working on complex products. Nice to Have: Experience ... with medical devices and regulation - ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as medical devices, and IEC 62304. Experience performing risk… more
- Fujifilm (Boston, MA)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- System One (Harvard, MA)
- …sound decisions, Independently This position will regularly interact with: Reporting Manager Sometimes will interact with departments listed below: Quality Control ... ASQ or ISPE. + Prior experience of QC equipment Qualification and some project management experience + Knowledge of biotech, bulk drug substance or finished product… more
- Cardinal Health (Mansfield, MA)
- …and documentation practices. **_Job Description:_** Under the direction of the Manager of R&D, this individual will be primarily supporting maintenance of ... (DHF) Documentation and adherence to guidelines and requirements associated with FDA /QSR design controls. + Participate in multi-departmental teams to manage product… more
- North Coast Seafoods (Boston, MA)
- …usability of products. This position reports to the Quality Control Supervisor or Manager . DUTIES AND RESPONSIBILITES + Serve as the primary contact between the ... mathematical concepts + Strong analytical and problem-solving skills + Strong project management and organizational skills; able to prioritize and manage multiple… more