- Philips (Cambridge, MA)
- …of the product life cycle + Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned ... a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in a cGMP Engineering role within pharmaceutical, biotechnology, or other FDA regulated industry. + Proficient understanding of instrumentation, and its ... and ASTM 2500 principals + Understanding of AF Analytics and SIMCA Software + Virtualized Server Infrastructure and Networking technologies + Demonstrate competence… more
- Fujifilm (Boston, MA)
- …+ Provide on-going customer support for HCUS MRI products, including: + Software updates. + System upgrades. + Performance troubleshooting follow-up visits. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Charles River Laboratories (Shrewsbury, MA)
- …a professional manner with management, coworkers, and sponsors. Experience with computer software programs is required. PHYSICAL DEMANDS: * Employees must be able to ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- AbbVie (Worcester, MA)
- …Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design, ... relevant experience required. + 10+ years' experience developing and maintaining automation software and equipment and PLC systems in a manufacturing environment; AI… more
- Fresenius Medical Center (Lawrence, MA)
- …devices including translating user needs into design requirements and developing software applications to improve knowledge retention and reduce training time of ... healthcare professionals; + Working on the FDA approval strategy, pre-submission process, and compilation of a pre-submission documentation; + Using computational… more
- Charles River Laboratories (Shrewsbury, MA)
- …prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft(R) Excel, Word, PowerPoint, etc. and with standard laboratory ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… 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