The Engineering Manager will be responsible for technical/engineering aspects of the production line performance, including design for manufacturability, production tooling, configuration management & optimization and monitoring manufacturing.
The main task is to allow production of high quality goods efficiently using GMP, Lean and other cost-effective methods.
• Leads engineering activity regarding Configuration management, design changes (ECO), NPI, test method and tooling design, monitoring and continuous improvement of manufacturing processes
• Leads engineering investigation and Failure Analysis activities in Operation, on component, product or process level
• Plan and execute process validation / jig validation
• Manage scrap reduction and yield improvement activity in manufacturing processes
• Main engineering point of contact to suppliers and vendors, considering quality of materials and manufacturing processes
• Supports MRB processes in Operation, assisting with issues relating to CAPAs, complaints and manufacturing support
•Education: BSc. Degree in relevant field, Mechanics or Biomedical preferable
o Good understanding of manufacturing processes, experience in a medical devices industry - an advantage
o Professional experience as a manufacturing engineer - 5 years
o Professional experience with multi discipline product of 2-3 years
o Good understanding in pneumatic and mechanics- a must
o Professional experience with Solidworks
o Clean room work experience – an advantage
o Familiarity with FDA and ISO 13485 medical device regulations.
o Familiarity with Design for Manufacturability and Assembly (DFM / DFA) is desired.
o Good analytical skills, self-starter with drive, focus, and initiative.
• Language skills: Good English, both written and verbal
o Self-starter with drive, focus, and initiative
o Good communication and interpersonal skills
o An ability of technical leadership in matrix and changing environment.