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MANUFACTURING ENGINEER II - INTERVENTIONAL PRODUCTS - 2025-5156
Minneapolis, MinnesotaAbout 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.
Position Summary
The Manufacturing Engineer ll - Interventional Products will be responsible for leading the manufacturing of product and implementation of improvements including cost, manufacturability, and quality goals. Responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes such as: machining, packaging, welding, assembly, and molding. This position will focus on catheter device manufacturing development including device coating processes as well as provide direction and support for existing products including support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.
Responsibilities
- Initiate and complete technical activities leading to new or improved 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
- Interfaces with quality and manufacturing to integrate new products or processes into the existing production area
- Maintain and approve device routers and bill of materials
- 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
- Resolve non-conformances and participates on Material Review Board
- Analyze and map processes, assesses efficiency, and implements complex project activities
- Assist with part cost estimation
- Support and comply with the company Quality System, ISO, and medical device requirements
Qualifications
- Bachelor’s Degree in Mechanical, Industrial, or other Engineering Science
- Familarity with test method development
- 3 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
- Manufacturing process design and validation
- Manufacturing equipment and fixture/gauge design
- Experience in an ISO13485/GMP environment
- Engineering experience with medical devices
- Lean manufacturing experience
- Knowledge of materials and related processes
- Project management experience
- DOE, SPC, FMEA, GMP, QSR
- Manufacturing automation, including electronic visual inspection
- 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)
- High level of 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)
- Clear and effective verbal and written communication skills
- Ability to work in a manufacturing environment
Preferred Knowledge, Skills and Abilities
- Experience with medical catheter manufacturing and Hydrophilic coating strongly preferred
- Continuing Education; including participation in local chapters, associations, and/or organizations
- Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)
- Knowledge of statistical software
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.