Process Engineering Manager

A medical device company that develops and manufactures innovative medical equipment. Specifically, the company develops cutting edge wearable drug delivery devices.
  
Job Description:  
The Process Engineering Manager will be responsible for technical/engineering aspects of the production line performance, including design, optimization and monitoring manufacturing processes.
The main task is to allow production of high quality goods efficiently using GMP, Lean and other cost-effective methods.
Leads engineering activity regarding process optimization and capacity improvement, monitoring and continuous improvement of manufacturing processes.  
Leads engineering investigation and Failure Analysis activities in Operation, on component, product or process level.
Leads engineering activity regarding design changes, test method and tooling design.  
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.  
Supports Supply Chain in cost reduction activity.    
 
Job Requirements:
Education: BSc. Degree in relevant field, Mechanics or Biomedical preferable      
 
Job Skills:      
Good understanding of manufacturing processes, experience in a medical devices industry – an advantage
Professional experience as process/manufacturing engineer – 5 years   
Professional experience with multi discipline product of 2-3 years   
Good understanding in pneumatic and mechanics- a must   
Professional experience with Solidworks – a must   
Clean room work experience – an advantage   
Familiarity with FDA and ISO 13485 medical device regulations.   
Familiarity with Design for Manufacturability and Assembly (DFM / DFA) is desired.   
Good technical abilities and technical curiosity   
Position responsibilities require project management skills and multi-tasking ability.   
Good analytical skills, self-starter with drive, focus, and initiative.      
  
Language skills:
Good English, both written and verbal  
 
Personality:     
Self-starter with drive, focus, and initiative   
Good communication and interpersonal skills  
An ability of technical leadership in matrix and changing environment.