Manufacturing Engineer III (New Product Development)

Overview

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 .

Summary

Ma nufacturing Engineer II I P osition Summary

The Manufacturing Engineer lll is responsible for leading the manufacturing process development of new products and implementation of new manufacturing processes.This position will also be responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes (such machining, packaging, welding, assembly, and molding).

Responsibilities

Ma nufacturing Engineer II I Duties and Responsibilities

• Supports new product development team within Cretex Medical - working on projects that are aimed on bringing in new technology and manufacturing solutions to Cretex Medical
• Responsible for creating manufacturing solutions for new projects either customer driven or internally driven
• Interface with external and internal stakeholders of the project and take ownership of providing timely project updates, communicating schedule, risks, or delays.
• Owner of process flow and implementation of all processes required for assigned project/product
• Support implementation of new technology to Cretex Medical - may include vendor selection, equipment ordering, IQ/SAT, process development, and training.
• Write Technical reports summarizing builds as well as maintain applicable work instructions.
• 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 with quality and manufacturing to integrate new products or processes into the existing production area
• Maintain and approve device routers and bill of materials
• 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
  
  

Qualifications

Ma nufacturing Engineer II I Requirements

• 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
• Project management experience
• 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
  
  

Ma nufacturing Engineer III P referred Knowledge, Skills and Abilities

• Continuing Education; including participation in local chapters, associations, and/or organizations
  
  

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.

Company Benefits

Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay.

Cretex Medical also offers company-specific benefits, such as:

• Employee Appreciation events
• Volunteer Opportunities
• Training and Development opportunities
• Tuition Reimbursement
• New state-of-the-art facility in Brooklyn Park!
  
  

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity , disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify .