- Fujifilm (Boston, MA)
- …but are not limited to internal and third-party product testing and validation , systems functionality and availability, business continuity and disaster ... to quickly learn new technologies are required. + Bachelor's degree in computer science, Information Systems , Healthcare Informatics, or related field (or… more
- Integra LifeSciences (Braintree, MA)
- …quality control microbiological laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... and checklists. + Assist as needed in test method validation , investigation studies or other product development studies. +...studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Integra LifeSciences (Braintree, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations such as...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
- Medtronic (Boston, MA)
- …future issues. + Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed. ... R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the… more
- Globus Medical, Inc. (Methuen, MA)
- …focused on advanced development and product innovation for surgical navigation systems . This role is critical in shaping next-generation medical devices that ... navigation. + Ensure robust software architecture and integration with hardware systems . + **Product Development** + Collaborate with clinical experts, product… more
- Hologic (Marlborough, MA)
- …software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD). In this role, you'll lead design controls, risk management processes, ... and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest...Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485,… more
- J&J Family of Companies (Danvers, MA)
- …and system monitoring **Qualifications:** + Bachelor's or Master's in Computer Science, Electrical/ Computer Engineering, or Embedded Software Engineering. + ... **Job Function:** R&D Product Development **Job Sub** **Function:** R&D Software/ Systems Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:**… more
- Integra LifeSciences (Braintree, MA)
- …is responsible for maintaining, troubleshooting, and repairing refrigeration and HVAC systems critical to our production and storage environments. The ideal ... in regulated industries and a strong understanding of refrigeration systems , compliance standards, and preventive maintenance practices. This position plays… more
- Cardinal Health (Boston, MA)
- …CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), ... products company. We provide customized solutions for hospitals, healthcare systems , pharmacies, ambulatory surgery centers, clinical laboratories, physician offices… more