Senior Manufacturing Engineer - Electrophysiology

JOB PURPOSEExecute manufacturing engineering actions, projects and investigations assuring the sustaining of production lines according to quality compliance regulations.
MAJOR RESPONSIBILITIESCoordinate the engineering process to allow the execution of priorities and projects according to manufacturing production needs.Coordinate with different areas (logistics, purchasing, planning and quality) assuring that production running without interruptions and products and processes improvements are in compliance with standards and quality system.Implement continuous improvement projects in products and processes to reduce the risks of interruptions in production or quality regulations.Keep a foster organizational environment to promote HMCR values and culture.Developed processes, documentation and records, after production release assuring the manufacturing and quality regulations.Execute manufacturing priorities and process according to the indicators of yield, quality, and cost, through methodologies (Six Sigma DMAIC, DOE’s, Lean) assuring the SPCs.Perform manufacturing technical support during the validation, and post-production to avoid line interruptions and high scrap.
KNOWLEDGE, SKILLS AND ABILITIESElectrical/Electronic Engineering; Mechatronics or related Bachelor´s Degree.Engineering Master’s degree in field related is desirable.5+ years in similar positions.4+ years of work experience in medical industry. Catheter experience preferred.Intermediate-Advanced in spoken and written business English.Transfer Process Projects implementation experience.Experience supporting production lines and leading root cause investigations used problem solving methodologies.Continuous improvement projects implementation experience.Validation medical manufacturing process experience.Statistical techniques knowledge (DOE, SPC, etc.) is required plus experience with continuous improvement methodologies.Proficient in using SAP is desirable.Normative ISO13485 and FDA.Lean and six sigma knowledge.Knowledge in CAPEX, Budget control and COGS.Software: Minitab.Software: AutoCad & Solidworks are nice to have.Highly Analytical, organized and business/service oriented.