Denver Metropolitan Area
Experienced Manufacturing and Quality Engineer with a demonstrated history of working in the medical device industry. Skilled in DMAIC, Verification and Validation (V&V) and Lean Manufacturing. Strong operations professional with a BSME focused in manufacturing from Colorado State University.
Advanced manufacturing engineering support for NPD process and teams.
Responsible for supporting manufacturing operations including developing metrics, supporting incoming inspection processes and investigations, and MRB. Manage Corrective Action and NCMR processes. Led site implementation of AS9100.
Responsible for manufacturing process development for medical device new product introductions. Participated in projects to define manufacturing processes and components; process qualification and validation of new products and components, sustaining engineering of existing processes and devices.
Responsible for operation of nuclear medicine manufacturing (I-123 capsules) including management of preparation, production, packaging and customer service in compliance with local, city, state, federal and company guidelines.
Responsible for management of sustaining quality issues, NCR system, root cause investigations, responses to corporate/BSi/FDA audits/investigations. Lead and direct MRB. Managed and conducted investigation and root cause investigation of electrosurgical generator programming errors for CAPA response and implementation. Work with PCB suppliers to overcome supplier quality issues.
Implemented in house manufacturing process for vessel sealer heating element resulting in annual savings. Utilized SPC charts to monitor jaw gap reducing non-conforming product by 20%. Responsibilities include process qualification and validation of new products and components, sustaining engineering of existing processes and devices; new medical device package qualification. Conversion of existing products to meet RoHS requirements.