Job Information
Cretex Medical Component and Device Technologies Manufacturing Engineer III (New Product Introduction) in Brooklyn Park, Minnesota
Overview 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. Responsibilities 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
- Understand customer needs and the core business markets we serve
- Ensure business systems are implemented, maintained, and functioning properly
- Participate in required company meetings
- Maintain an organized work area (5S)
- Participate in the Operational Excellence Program
- Complete all other work duties as assigned
- Ability to work in a manufacturing environment
Qualifications Minimum Requirements, Education & Experience (incl. KSA's and certifications)
- 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)
- Clear and effective verbal and written communication skills
- Attention to detail
- Organizational skills
