A medical device company that develops and manufactures innovative medical equipment. Specifically, the company develops cutting edge wearable drug delivery devices.
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.
Education: BSc. Degree in relevant field, Mechanics or Biomedical preferable
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.
Good English, both written and verbal
Self-starter with drive, focus, and initiative
Good communication and interpersonal skills
An ability of technical leadership in matrix and changing environment.