Experience

IZI Medical

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Sr. Process Engineer

  • May 2019 - Present



Integra LifeSciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Manufacturing Engineer Intermediate

  • Jan 2016 - Present

  Currently conducts manufacturing positioning of new product presentation and existing product improvements for neurosurgical stabilization systems (Mayfield) by developing manufacturing and assembly processes. Provides daily manufacturing support for producing parts at the finishing and assembly areas, improve product manufacturability and quality by facilitating employees tasks on the floor.• Supports process and/or product improvements via team collaboration with Quality, Manufacturing, R&D, Finance, and Marketing• Develops process characterization tests for any outsourced part(s) by interfacing with new suppliers/vendors to define, document, analyze, and qualify their manufacturing processes to optimize Integra’s production output.• Maintains responsibility for supporting product development activities through input to design for manufacturability• Performs design or process validations/verifications to justify any changes involving the products’ materials, dimensions, and manufacturability. • Executes protocols, reports, and engineering studies for IQ, OQ, PQ activities to quality new processes and implementing new machinery/equipment onto the manufacturing floor. • Sustains current manufacturing processes by working alongside operators reactively and proactively on internal processes. • Improves documentation of manufacturing processes (routers, BOMs, Inspections, Work Instructions) and develops manufacturing processes to launch new products. • Conducts material transfer plans for both insourcing and outsourcing various products as well as introducing new vendors• Solves manufacturing issues via Non-Conformance Material Report (NCMR) by troubleshooting and retraining staff as well as updating work instructions from the Device Master Record. • Active member of the Material Review Board analyzing, investigating, and dispositioning non-conforming components and products.

• Manufacturing Engineer (Complaint/CAPA Engineer)

  • Nov 2012 - Jan 2016

  Served as a Complaint Investigator Engineer reviewing clinical and technically-based costumer complaints by analyzing non-conformant neurosurgery medical devices from the field. Performed root cause investigations on returned devices and documented with robust technical information. Implemented corrective and preventative (CAPA) plans originated from customer complaint trends. Monitored field product performance through evaluation and trending of customer complaints through the marketing sales team.• Executed risk assessment activities for each complaint case in terms of severity and alerted the Quality CAPA Engineer Manager of any trends. • Managed customer correspondence regarding manufacturing/quality issues and problems emanating from complaints• Assessed risks from customer field complaints and provided solutions on functional challenges. • Created FMEA/PFMEA to update risk management data system• Provided technical support to Quality CAPA team in composing engineering evaluations for complaint closures• Coached Japanese distributors, OHWA, on the Mayfield products’ functionalities, assemblies, and inspections. • Developed process towards reworks, repacks, and scrap of returned products from the field. • Led regular project meetings internally, worked with cross-functional team to provide timely project updates and prioritize critical projects• Created a controlled form, Engineering Complaints Form, which allowed Engineers to present complaints investigations• Performed CAPA investigations in accordance with ISO 13485:2003 & FDA Quality System Regulation (21 CFR 820) standards to determine the root causes and implement the solutions accordingly• Updated and revised controlled documents from the Device Master Records and any other technical documents including the Design History File