Sean Hepner Email & Phone Number

Phoenix, Arizona Area

Delivery System Accessories – Contract Manufacturing Process Engineer- Liaison between Gore and the companies that contract manufacture some of our products. - Update specifications and design control documentation while coordinating and managing supplier changes.- Created multiple product manufacturing line pFMEA's.- Drove updates to dFMEA/pFMEA/uFMEA for multiple product lines to comply with new external FMEA standards.Class III Stent Grafts – Manufacturing Process… Show more Delivery System Accessories – Contract Manufacturing Process Engineer- Liaison between Gore and the companies that contract manufacture some of our products. - Update specifications and design control documentation while coordinating and managing supplier changes.- Created multiple product manufacturing line pFMEA's.- Drove updates to dFMEA/pFMEA/uFMEA for multiple product lines to comply with new external FMEA standards.Class III Stent Grafts – Manufacturing Process Engineer- Formerly supported a legacy manufacturing line, and then the design transfer team for the next generation product line driving change orders and process related improvements.- Collaborate with mechanical and software engineers to create equipment utilizing various tools such as vision systems, automation, and error proofing.- Write and execute IQ/OQ’s and SQA’s for equipment, as well as PQ’s for manufacturing lines.- Create fixtures and tooling level assemblies within SolidWorks.- Drive non conformance report’s and utilize root cause analysis methodology for process failures- Support audit activities.- College recruiting/outreach.- Formal mentor for other associates.- Engineering level reviewer for quality system documents. Show less

Oro Valley, Arizona

Automated Tissue Staining Machines – R&D Systems Integration Engineer- Hands-on systems integration of automated machinery for pathology- Develop/perform/report out on experiments to define final specifications- Invent/implement/improve mechanical and fluidic processes- Conduct design reviews of integrated component- Assist the mechanical, chemical, and software development of modules- Collaborate across multiple engineering/scientific disciplines- Expert… Show more Automated Tissue Staining Machines – R&D Systems Integration Engineer- Hands-on systems integration of automated machinery for pathology- Develop/perform/report out on experiments to define final specifications- Invent/implement/improve mechanical and fluidic processes- Conduct design reviews of integrated component- Assist the mechanical, chemical, and software development of modules- Collaborate across multiple engineering/scientific disciplines- Expert software/electrical/chemical/mechanical troubleshooting - Utilized SCRUM/Agile project management methodology- Plan validation activities Show less

Tempe, Az

Bard Peripheral VascularVena Cava Filters ➢ Worked through multiple product lifecycles ➢ Considerable experience with welding, annealing, testing, and working with Nitinol ➢ Constructed and validated new test methods, modified existing methods to make them faster and more efficient ➢ Piloted small projects to pass equipment through Gauge R&R’s ➢ Designed new innovative fixtures for use in manufacturing and incoming inspection

SmartShield-➢ Created a lead acrylic moveable shield as an alternative to bulky lead aprons used during fluoroscopy➢ Submitted an Arizona Radiation Regulatory Agency submission➢ Experience with proper Quality/FDA documentation• Written Premarket Application• Compiled a DHF, QSR, DMR and DHR➢ Project mentioned in Wall Street Journal

Posting insurance payments to patient accounts.Proficient in written communication skills, attention to detail and organization. Professional team player, able to manage hours and work with little supervision.Former Titles:Medical TranscriptionistDay Charts Team Member

Usher, door, and concession services.