Senior Engineer, Production

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. 

Are you looking for an inspiring career? You just found it.

 

Job Overview

Supports the commercialized production of medical devices. Works within manufacturing engineering functions to provide technical support for the quality of the product, process development, continuous improvement, and process control.

 

Job Responsibilities and Essential Duties

• Works in team setting, independent setting, provides oversight to other junior team members.
• Supports production / manufacturing.
• Organizes and leads efforts to drive down scrap and reduce equipment downtime.
• Modify and improve existing equipment.  Improve manufacturing efficiency, production yields, product quality and consistency through equipment and product design.
• Responsible for all aspects of Process Validations, protocol writing, executing, and reports for IQ, OQ, PQ, EAT, & TMV.
• Perform process improvement initiatives. 
• Supports / Leads non-conformance investigations, CAPA activity, OOT’s, Customer complaints, PFMECA’s, MES, supply chain activities, and equipment troubleshooting.
• Leads large scale projects for prototype and production equipment design for producing medical devices and components.
• Executes large scale highly complex change orders (ECO’s) related to process and equipment documentation.
• Analyzes and documents test results for development and pilot production runs.
• Assist with new product introduction, associated manufacturing methods and their transfer into production.
• Own and manage MRB including non-conformance investigations and CAPA activities.
• Advanced equipment troubleshooting.
• Protocol and report writing
• Identify and resolve component / supplier related problems.
• Work independently / Lead teams
• Must have a strong data driven approach.
• Perform other related duties as required.
• Strong ability to lead large scale projects / program management skillset required.
• Ability to advance the manufacturing technologies employed at Getinge.

Minimum Requirements

• Bachelor’s Degree or Advanced degree in Engineering, or equivalent work experience.
• Five to Seven years related manufacturing experience (medical device field is preferred).
• Advanced knowledge in statistics and SPC methods preferred.
• Knowledge of FDA Code of Federal Regulations 21 and ISO standards preferred. 
• SolidWorks and Minitab experience highly desired. 
• Advanced skills in equipment troubleshooting (Electro-mechanical), problem solving and analysis.
• Advanced computer skills, including MS Office applications (Word/Excel/PPT/visio/minitab).