Process/Sustaining Engineer (Extrusion)

Real Staffing Group is urgently seeking a Sr. Process Extrusion Engineer for a leading medical device company in the Carpinteria CA area.

This role will be given to someone who will:
* Provide sustaining engineering support for all existing processes and production on daily basis.
* Can identify and troubleshoot existing extrusion process inefficiencies focused on quality and efficiency improvements.
* Optimize and implement set ups to meet or exceed engineering standards while meeting all customer requirements in accordance with all documents, including but not limited to MP's, SOP's, Shop orders, QCIC's.
* Implement, update to assure compliance of processes with Helix QS, QP's, SOP's, HTM's MP's and LEAN Principals.

Main responsibilities include:
* Focus on daily customer and process related issues to improve quality, on time delivery and process efficiencies.
* Provide Engineering support for all manufacturing Kaizen events.
* Support and develop validation protocols and reports (IQ/OQ/PQ) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
* Support MRB and EO/DCN(Engineering Change/Document Change Notice) received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes
* Maintain complete and accurate records of assigned project activities per established Quality System.
* Conceptualizes and develops lean manufacturing processes for new and existing business opportunities, which may include new and/or modified plant equipment and process needs.

Requirements:
* Bachelor of Science degree in engineering, preferably plastics or mechanical engineering.
* Minimum 7 years experience working as an extrusion process engineer in medical device companies.
* Previous experience or training with project management techniques.
* Experience with Scientific Injection Molding Principles in a related manufacturing environment
* Familiarity with statistical problem solving and six sigma techniques.
* Experience with validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis and recommendation reports.
* Attention to detail and able to work independently and on a team with little supervision
* CAD proficient in 2D dimensioning and tolerance.
* (Desired) Previous experience in extrusion manufacturing environment of medical or Healthcare products and familiarity with ISO-13485 and FDA CFR 21 regulations
* (Desired) Six Sigma Green or Black Belt certification

To find out more about Real Staffing please visit www.realstaffing.com