- 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
- J&J Family of Companies (Danvers, MA)
- …Engineering, or Computer Engineering. + 12+ years of experience in hardware/ system engineering, with 5+ years in leadership roles. + Proven track record in ... hardware products. This role requires strong technical depth in hardware systems engineering, medical device product development, and leadership skills to drive… more
- Catalent Pharma Solutions (Chelsea, MA)
- …experience, preferably in cGMP biopharmaceutical, pharmaceutical, medical device, food, or other FDA regulated industry + Must have basic computer skills - ... consumer, and Catalent employee.** **The Role:** + Provide support for validation , calibration, and preventative maintenance of all Good Manufacturing Practices… more
- Medtronic (Boston, MA)
- …from assessment through to procedure production release including equipment installation and validation activities + Lead development of a system -based approach ... + Develop and implement the SPC KPI and tracking system across manufacturing + Develop alignment for process and...the project lifecycle + Medical device / regulated / FDA environment + Developed and implemented culture change +… more
- Fresenius Medical Center (Waltham, MA)
- …+ Work with Quality Assurance to meet the requirements of our internal Quality System , including specific requirements of GMPs, FDA QSR, relevant IEC standards, ... + Assist in Integrating NxStage Medical's products with customer systems . + Assist with researching and resolving software related...to relevant SOPs. **Education & Qualification:** + BS in Computer Science with a focus on software design and… more
- Medtronic (Newton, MA)
- …design, development, and maintenance of software for Affera cardiac electrophysiology systems . By blending technical expertise with a passion for quality, ... efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. + Serve as the Quality… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... + Performs tasks in a manner consistent with the safety policies, quality systems , and GMP requirements. + Completing training assignments to ensure the necessary… more