- Olympus Corporation of the Americas (Westborough, MA)
- …activities such as defining system requirements, Sub-system requirements and software requirements and the associated specifications, making system architecture ... the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304. +… more
- Danaher Corporation (Boston, MA)
- …emergency department triage efficiency and patient outcomes-and Etiometry, an FDA -cleared platform that supports proactive, personalized care in intensive care ... Sales and Marketing and is part of the Clinical Software Sales Team working remotely to cover the Eastern...also possess previous experience in: + Selling AI-powered or software -based healthcare solutions. + Working with emergency departments or… more
- Olympus Corporation of the Americas (Westborough, MA)
- …knowledge of medical device design control requirements, system design and software and hardware integration and testing, and design for manufacturability and ... the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304. +… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers… more
- Bristol Myers Squibb (Devens, MA)
- …Skills:** + Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices. + Comprehensive ... knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how to work and manage within a regulatory environment. +… more
- Bristol Myers Squibb (Devens, MA)
- …tools like MS Office, etc., and ability to learn and work with new software applications. + Advanced ability to interpret data & results, understand complex problems ... environment with limited information and/or time-constraints. + Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.… more
- J&J Family of Companies (Danvers, MA)
- …signal quality, and troubleshoot noise or cross-talk + Collaborate with software , systems, and electrical engineers to support signal processing, calibration, and ... test plans, verification protocols, and technical reports in compliance with FDA guidance + Present design updates, feasibility findings, and risk assessments… more
- Dana-Farber Cancer Institute (Methuen, MA)
- …compliance with all regulatory agency (eg Joint Commission (formerly JCAHO),CAP, FDA , AABB) requirements. + Manual/visual dexterity necessary to prepare specimens, ... prepare solutions, screen specimens and operate a computer software system. + Ability to perform venipuncture techniques. At Dana-Farber Cancer Institute, we work… more
- ZOLL Medical Corporation (Boston, MA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Medtronic (Billerica, MA)
- …or equivalent systems. + **Programming:** Set up, configure, and validate firmware/ software builds on capital equipment using proprietary test environments and ... electrical test equipment and basic troubleshooting + Experience in a regulated environment ( FDA , ISO 13485) + Ability to read and interpret schematics, BOMs, wiring… more