Ensure on-market engineering and new product development teams for serialized devices/consumable products utilize appropriate design control processes and engineering analysis while designing quality into products during product development/design changes.Assist with the development of responses and effectiveness checks of internal audit assessments and provide support during external regulatory inspections.Partner with technical investigator to perform formal investigations and lead CAPA action plans to closure for medical device and corporate quality compliance issues.Responsible for ensuring projects maintain compliance to corporate policies and procedures while ensuring compliance with applicable regulatory requirements. Maintain understanding and solid awareness of quality system and technical regulatory requirements (e.g.: 21CFR820, ISO 13485:2003, ISO14971:2007, IEC 60601).

In addition to validation role, acted as usability subject matter expert for engineering team.Led the development, revision, and review of program documents to assure compliance to IEC 62366, 60601-1-6 usability standards. Developed and conducted current user focused workgroup sessions to deliver feedback to the engineering team during product design and planning phase.Developed and conducted successful usability testing for evaluation of new features by current users. Positive outcome increased engineering confidence in product design prior to commercial release.

Led validation efforts for new product development and on market maintenance programs for both hardware and software platfor.s Developed test plans and schedules, allocation of resources, and identification of appropriate test methods, use case protocols, and system configurations. Developed, maintained, and executed use case test protocols to. Developed validation test plans and associated and test reports to demonstrate traceability from risk controls and/or user needs to product design requirements.Developed and maintained a systemic approach to classify, organize, and maintain laboratory test equipment which was: not calibrated, routinely calibrated to OEM specifications, or required scheduled preventative maintenance (PM). Developed, maintained, and executed PM procedures on laboratory test equipment used for verification and validation to ensure proper functionality. Coordinated calibration of lab hardware equipment and tooling, maintenance of calibration records, and calibration record assessments.Provided training and support to engineering team in Bangalore, India on product use, verification/ validation testing, and equipment maintenance/calibration.

Interface with Engineering, Service Engineering, and Validation teams to devlop and verify/validate instructions for use and with installation/ service documentation during new product development.