- J&J Family of Companies (Danvers, MA)
- …for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop and maintain ... **Job Function:** R&D Product Development **Job Sub** **Function:** R&D Software/ Systems Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …data (eg, case processing, MedDRA coding) is highly desirable + Knowledge of data integrity, system validation , and computer system compliance (21 CFR ... codelists, etc within safety database. + Monitor the performance of safety systems , troubleshoot data discrepancies, system errors, and identify process… more
- Teleflex (Mansfield, MA)
- …experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems , strongly desired * Experience in ... and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and Quality procedures and… more
- 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
- 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
- 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
- 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