Validation engineer — medical devices location: united states industry: medical devices role summary we are seeking an experienced validation engineer to support validation activities for medical device manufacturing processes, equipment, test methods, and systems.the role requires strong hands-on expertise in iq/oq/pq execution and compliance with global medical device regulations.key responsibilities develop, review, and execute iq/oq/pq protocols for manufacturing equipment and processes perform process validation and test method validation (tmv) support computerized system validation (csv) where applicable author validation plans, protocols, reports, and traceability documentation conduct risk assessments and support pfmea activities investigate deviations and support capa implementation ensure compliance with design controls and validation lifecycle requirements collaborate with quality, manufacturing, r&d, regulatory, and supply chain teams support audits and regulatory inspections required qualifications bachelor's degree in engineering or related technical field experience in medical device validation or regulated manufacturing strong hands-on experience with iq/oq/pq execution knowledge of process validation and tmv familiarity with fda 21 cfr part 820, iso *, and iso * experience with change control, deviations, and capa processes strong documentation and technical writing skills preferred qualifications experience with class ii or class iii medical devices knowledge of software or computerized system validation (csv) familiarity with statistical tools (minitab, spc, etc.) Ability to manage multiple validation projects