The primary objective of the position is to drive and execute strategic projects for continuous improvement in production processes, including automation assessments. Along with the controller, this position is responsible for forecasting the return on investments for large capital equipment. Other responsibilities include specification, and validation of large capital manufacturing equipment, process development, and documentation. This position will work closely with management and the production staff.
Major Responsibilities of the Position:
Drive strategic manufacturing projects for continuous improvement; both managing and directing these projects.
Evaluate, specify and procure large capital equipment.
Develop new and improve existing processes.
Process qualification and validation (Including IQ, OQ, & PQ).
Lead transfer technology and process from Switzerland to Andover.
Develop and write process documentation.
Measure and evaluate production quality and output.
Lead Cost Improvement Projects.
Design Tooling and Fixturing for production.
Train all manufacturing personnel with respect to execution of various projects.
Participate in CAPA & NCMR process as required.
Minimum Qualifications :
Bachelor of Science in Engineering or equivalent.
10+ years of experience in a medical device or regulated industry.
CAD experience a plus.
CNC machining experience a plus.
Required Knowledge and Skills:
The ability to work independently in a dynamic manufacturing environment.
Knowledge of GMP and ISO requirements.
Good written and oral communication skills.
Experience leading and directing multiple projects.
Some experience managing people, preferred.
The ability to train employees at all levels
|Straumann USA LLC|
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