Validation engineer — medical deviceslocation: united statesindustry: medical devicesrole summarywe 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 responsibilitiesdevelop, review, and execute iq/oq/pq protocols for manufacturing equipment and processesperform process validation and test method validation (tmv)support computerized system validation (csv) where applicableauthor validation plans, protocols, reports, and traceability documentationconduct risk assessments and support pfmea activitiesinvestigate deviations and support capa implementationensure compliance with design controls and validation lifecycle requirementscollaborate with quality, manufacturing, r&d, regulatory, and supply chain teamssupport audits and regulatory inspectionsrequired qualificationsbachelor's degree in engineering or related technical fieldexperience in medical device validation or regulated manufacturingstrong hands-on experience with iq/oq/pq executionknowledge of process validation and tmvfamiliarity with fda 21 cfr part 820, iso *, and iso *experience with change control, deviations, and capa processesstrong documentation and technical writing skillspreferred qualificationsexperience with class ii or class iii medical devicesknowledge of software or computerized system validation (csv)familiarity with statistical tools (minitab, spc, etc.)ability to manage multiple validation projects