Senior Medical Device Manufacturing Engineer
Our client is a large medical device manufacturer. They develop and manufacture a number of class 3 medical devices- primarily catheters. They are in need of a Senior Manufacturing Engineer with a Medical Device take on sustaining activity across multiple projects, while full time personnel focus on a new Document Control PLM system upgrade from Agile to Windchill.
This person will be responsible for handling several Manufacturing Engineering activities associated with a variety of ongoing projects within the company. The support is needed over the next 12-18 months while some FTEs are assigned to an Agile to Windchill PLM upgrade/transformation. This person should come from a background of 7-12 years in the Medical Device industry, working as a Manufacturing Engineer. The role is focused on sustaining activity, and may include tasks like the following:
Manufacturing Engineering support, working in a hands on manner with manufacturing/technicians/on the floor etc.
Validation and validation documentation (Process, TMV, etc.)
Working within CAPAs from an engineering perspective
IQ OQ PQ, PFMEA & DFMEA, Failure Analysis, etc.
As well as other manufacturing based activity.
This person will be expected to be able to own projects independently as well as work cross-functionally with other groups. The role is for a self-starter, someone who is excellent in communicating progress to management, maintain proper documentation methods, etc.
Medical Device Manufacturing experience
Process Validation IQ OQ PQ
Class 3 Medical Devices
Highly motivated and effective communicator
Job Type: Contract