Zimmer Biomet Holdings
Process Engineer Senior I
The Process Engineer Senior I supports validation activities through performing the following: Collect and review data for assigned process validations, test method validations and IQ/OQ/PQs; Draft validation protocols and reports; Review and prepare supporting documentation, including SOPs, for assigned validations; Coordinate documentation reviews with other functional areas and assure approvals are completed as required; Write, develop, review, revise, and, as applicable, execute user/functional requirements specifications, risk assessments, validation plans, IOPQ protocols, decommissioning plans, trace matrices and final reports for equipment/processes, CSV/Software; and Perform validation project management duties as needed. Must have 3 years of experience in job offered or related position. Must have 2 years of experience with the following: working with FDA and ISO 13485 regulations as they relate to medical devices and/or in-vitro diagnostics devices; working in the in-vitro diagnostics devices field; and statistical sampling, blueprint reading, gauging concepts, and geometrical dimensions and tolerance. Must have 1 year of experience in Test Method Validation. Requires a Bachelor's in Engineering or related field. Role requires up to 5% domestic travel. 40 hours per week, Monday through Friday, 8:30 AM to 5:00 PM. CD Diagnostics Inc., 650 Naamans Road, Suite 100, Claymont, DE EOE/M/F/Vet/Disability
The Process Engineer Senior I supports validation activities through performing the following: Collect and review data for assigned process validations, test method validations and IQ/OQ/PQs; Draft validation protocols and reports; Review and prepare supporting documentation, including SOPs, for assigned validations; Coordinate documentation reviews with other functional areas and assure approvals are completed as required; Write, develop, review, revise, and, as applicable, execute user/functional requirements specifications, risk assessments, validation plans, IOPQ protocols, decommissioning plans, trace matrices and final reports for equipment/processes, CSV/Software; and Perform validation project management duties as needed. Must have 3 years of experience in job offered or related position. Must have 2 years of experience with the following: working with FDA and ISO 13485 regulations as they relate to medical devices and/or in-vitro diagnostics devices; working in the in-vitro diagnostics devices field; and statistical sampling, blueprint reading, gauging concepts, and geometrical dimensions and tolerance. Must have 1 year of experience in Test Method Validation. Requires a Bachelor's in Engineering or related field. Role requires up to 5% domestic travel. 40 hours per week, Monday through Friday, 8:30 AM to 5:00 PM. CD Diagnostics Inc., 650 Naamans Road, Suite 100, Claymont, DE EOE/M/F/Vet/Disability