Job Description:
The Production Engineer 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, products or process level
Writing and updating Work Instructions and Test Instructions
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 industrial Engineering, mechanics or Biomedical
· Job Skills:
o Good understanding of manufacturing processes, experience in a medical devices industry – an advantage
o Professional experience as a process engineer with multi discipline product – 3 years
o Good understanding in pneumatic and mechanics- a must
o Professional experience with Solidworks – an advantage
o Clean room work experience – an advantage
o Familiarity with FDA and ISO 13485 medical device regulations – an advantage
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
· Personality:
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.