NPI Engineer II

NPI Engineer II

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.

The NPI Engineer II will be responsible for the development, validation, and launch of new products into the production environment. Responsible for designing, validating and developing new products while working through a defined stage gate process. This position will also provide training and support to operators and technicians on NPI programs and launches.

• Initiate and complete technical activities leading to new processes or design for manufacturability for programs and to meet strategic goals and objectives for the company.
• Create process flow diagrams and support evaluation of efficiency, cycle times, yield, and scrap.
• Contribute to root cause analysis and troubleshooting efforts on equipment or processes to solve quality, consistency, and scrap problems.
• Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of problems which may require innovative approaches to validation and product design to meet customer deliverables.
• Create, maintain and approve device routers, bill of materials, and manufacturing procedures.
• Own development, characterization, and validation of new processes to output capable and stable processes using statistical analysis skills and tools (ex. DOE) where appropriate.
• Develop and lead discussions around risk documents such as pFMEAs and MVPs.
• Understanding of process validation (IQ/OQ/PQ) and statistical analysis including capability, confidence/reliability, etc. to support execution and documentation of validation activities.
• Act with appropriate speed and prioritization when project risks are identified.
• Iteratively design, fabricate, test, and implement process fixturing and gauging
• Support set-up, training, and setting development on new or novel pieces of equipment.
• Develop customer relationships and serve as technical resource on customer calls to exceed internal and external customer expectations and requirements.
• Participate as technical support in customer visits, key contact for customer projects
• Support cost evaluation in partnership with business development and technical solutions teams.
• Provide guidance and training to Engineering Technicians
• Interface with Quality, Development, and Manufacturing organizations to integrate new products or processes into the existing production area.
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Understand customer needs and the core business markets we serve
• Ensure business systems are implemented, maintained, and functioning properly
• Participate in required company meetings
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned
• Ability to work in a manufacturing environment

• Bachelor's Degree in Mechanical, Industrial, or other Engineering Science
• 3 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
• Process design and validation
• Equipment and fixture/gauge design
• Experience in an ISO
  13485/GMP environment
• Engineering experience with medical devices
• Knowledge of materials and related processes
• DOE, SPC, FMEA, GMP, QSR
• Manufacturing automation, including electronic visual inspection
• Proficient in 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)

Preferred Requirements:

• 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
• Lean manufacturing experience

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."

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