Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. + years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical or electrical equipment and/or components. Experience in validation of product and equipment. Experience in New Product Introduction (NPD) with Solidworks. Knowledge of good manufacturing practices and documentation, preferably in the medical industry. Risk management experience pFMEA and dFMEA. Knowledge on QMS - NC, CAPA and contribution in audits and ETQ instinct experience if any. Preferably with knowledge of ISO , FDA CFR Part and GMP. JnJ experience with ADAPTIV and Windchill PLM. Oral and written communication in English.