Manufacturing Engineer III - New Product Introduction

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.

Position summary

The Manufacturing Engineer lll (NPI) will be responsible for developing and launching manufacturing processes into the production environment. Responsible for validating, designing, developing, and training to manufacturing processes while working through a defined stage gate process. Provide direction and support for existing products including support to the Manufacturing organization within the production area as needed.

Essential Job Functions

• Initiate and complete technical activities leading to new or improved processes or design for manufacturability for 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
• Interface cross functional teams to integrate new products or processes into the existing production area
• Maintain and approve device routers and bill of materials
• Develop/Update risk documentation such as PFMEAs
• Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues
• Maintain and approve manufacturing procedures
• Design and coordinate fabrication and implementation of process fixturing or gauging
• Analyze and map processes, assesses efficiency, and implements complex project activities
• Assist with part cost estimation
• Mentor Engineer I and II
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance
• Ability to work in a manufacturing environment

• Bachelor's Degree in Mechanical, Industrial, or other Engineering Science
• 5 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
• Experience in an ISO13485/GMP environment
• Engineering experience with medical devices
• Manufacturing process design and validation
• Manufacturing equipment and fixture/gauge design
• Lean manufacturing experience
• Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)
• DOE, SPC, FMEA, GMP, QSR
• Knowledge of statistical software
• Knowledge of materials and related processes
• Manufacturing automation, including electronic visual inspection
• 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)
• Excellent communication and influencing skills
• High level of energy, personal accountability, and integrity
• Highly detail oriented; checks own work, keeps accurate records, organizes information effectively
• Ability to tolerate ambiguity, multiple priorities, and short deadlines
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right."
• "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it."
• "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives."

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.