Manufacturing Engineer II - Interventional Products
Cretex Medical Component and Device Technologies
- Brooklyn Park, MN
- Permanent
- Full-time
- 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
- 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
- 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
- “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.”