Accountabilities Create, maintain, and obtain approval of Design Verification Plans and Reports (DVP&R). Identify product... such as those produced or endorsed by, but not limited to, IEC, IEEE, NEMA, NEC, UL, AHRI, and ASHRAE. Understanding of Design for Six Sigma...
and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify... in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485...
and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify... in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485...
210,211, 820, ISO/IEC 17025 and ISO 13485 Develop and review test protocols, methods, and reports to ensure compliance... engineering methodologies (e.g., Gage R&R, DOE, FMEA). Experience with Laboratory Information Management Systems (LIMS...
and outcomes. Leadership Accountabilities Create, maintain, and obtain approval of Design Verification Plans and Reports (DVP&R... such as those produced or endorsed by, but not limited to, IEC, IEEE, NEMA, NEC, UL, AHRI, and ASHRAE. Understanding of Design for Six Sigma...
and radiation safety standards. Evaluate equipment purchase requests, review R&D experiments, and assess potential safety hazards... with IEC 60825, IEC 62471, and FDA/CDRH FLPPS standards. Knowledge of federal reporting requirements, including import/export...
21 CFR Part 820, ISO 13485, IEC 62304) and internal quality management system procedures. Collaborate cross-functionally.... From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves...
, standards, and career paths. Define validation strategy and coverage model – requirements, test cases, results – and own DVP&R... programs. Depth in DVP&R, requirements traceability, test design, and statistical analysis of results. Knowledge...
functional strategy (e.g. R&D, Manufacturing, Sales) of the business group Requires broad and comprehensive expertise... preferred. 21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366. 3D solid modelling (e.g...
- whatever your ambitions. About the role: We have an exciting opportunity for a Senior R&D Engineer focusing on Sustaining activities... with cross-functional teams, including R&D, Quality, Regulatory, Operations, Supplier Engineering, Sourcing, Supply Chain...