Senior Manufacturing Engineer

San Jose  ‐ Onsite
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Keywords

Description

Position Summary:
Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

Duties and Responsibilities:
-Design and develop manufacturing processes for new products and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost
-Responsible for ensuring proper documentation consistent with company's quality system.
-Responsible for knowing and planning activities consistent the company's quality policy and quality objectives
-Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP
-Responsible for identifying issues in manufacturing and resolving them per the quality system requirements
-Proactively work with QA/RA to ensure any and all issues are addressed per the requirements of the quality system and ISO 13485, MDD and QSRs
-Ensure changes to processes have thorough justification and where applicable, validated to meet the regulations and the Company's quality system
-Ensure new tools/jigs, fixture, equipment or modifications to existing such items are only introduced in manufacturing upon completion of IQ, OQ, PQ applicable to the tools/jigs, fixture, equipment
-Maintain accurate and timely preventive maintenance of equipment and tooling.
-Ensure the manufacturing processes meet the approved MPIs, STMs, QPIs, etc.
-Ensure all equipment, tool, fixtures used for testing are calibrated, as appropriate, and/or inspected/verified to be traceable within the Quality System (per SOP 0005) and conforming to their specifications
-Ensure the test protocols and reports are thorough, complete, provide all required details to reproduce the study at a later date. Ensure the data sheets for the studies are well designed to capture all required data
-Perform testing per GLP guidelines with emphasis to test sample identification, traceability, sterilization processing
-Develop protocols and perform product verification and validation testing.
-Perform process-related design tasks to support pilot manufacturing
-Support production of final product by troubleshooting manufacturing processes
-Identify suppliers and maintain relationships to ensure the delivery of superior components and services
-Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company's products
-Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions
-Support company goals and quality policy, quality objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations

Position Requirements:
-Must posses good interpersonal and communication skills, and work in a collaborative style
Good technical skills and proven engineering problem solving ability
-Must have the ability to mentor junior Engineers and Technicians
-Other duties as assigned

Education Requirements:
-Bachelor's Degree (Master's preferred) in Electrical, Manufacturing, Mechanical or Biomedical engineering or equivalent experience

Experience Requirements:
-Minimum of eight years experience in engineering preferably in the medical device and/or pharmaceutical industry preferred

Special Requirements:
-Experience using CAD tools (SolidWorks preferred)
-Strong understanding of engineering materials, component selection, and design for reliability and manufacturability

To find out more about Real please visit www.realstaffing.com
Start date
05/2014
From
Real Staffing
Published at
03.06.2014
Project ID:
715481
Contract type
Freelance
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