Manufacturing Engineer II - Sustaining - #1399134

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

Manufacturing Engineer II Position Summary

The Manufacturing Engineer II provides support to the Medical Plastic Injection Molding Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.

• Initiate and complete technical activities leading to new or improved products or processes for current and next generation programs and to meet strategic goals and objectives of the company.
• Analyze and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology.
• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards
• Lead in the installation, debug, validation, and training of new work cells - including acceptance testing of new equipment/automation/fixtures. etc
• Create, maintain and approve device routers/BOMs
• Create, maintain and approve manufacturing procedures
• Design, coordinate fabrication and implements process fixturing or gauging fixtures, equipment, automation, EOAT, Vision systems, Gages

• Resolve non-conformances and participates on Material Review Board
• Analyze and map processes, assess efficiency, and implement complex project activities
• Oversees equipment installation, modification, training and preventative maintenance development

• Bachelor's Degree: Engineering (Manufacturing, Mechanical, Industrial)
• 3+ years of engineering experience in an injection molding manufacturing setting with a strong preference towards medical molding and cleanroom operations.
• Medical Device experience required
• Manufacturing process design and validation, perform DOE's, IQ-PQ Validations
• Manufacturing equipment and fixture/gage design
• Lean manufacturing, including statistical analysis and 5S
• Manufacturing automation, including electronic visual inspection, PLC programming, Packaging development, testing and approval
• 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)
• High level of energy, personal accountability and integrity

• Ability to tolerate ambiguity, multiple priorities and short deadlines
• Ability to travel overnight, by land or air
• Ability to consistently achieve short and long term business results
• Ability to prioritize work and manage multiple tasks when needed
• Attention to detail

• Good communication skills
• Strong problem solving skills