NPI Engineer III

NPI Engineer III

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 III will be responsible for developing, validating, and launching new products into the production environment. Responsible for validating, designing, developing, and training for new products while working through a defined stage gate process. This position will also provide support to the NPI organization to provide mentorship and support cross functional projects between NPD, Quality, and Manufacturing.

Essential Job Functions:

• Initiate and complete technical activities leading to new or improved processes or design for manufacturability for programs and to meet strategic goals and objectives of the company.
• Ideate process flow diagrams to map processes and assess efficiency, cycle times, yield, and scrap to provide quantitative data on the stability on new processes.
• Lead 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 complex and advanced problems which 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 providing risk-based feedback to meet both quality and customer timeline requirements.
• Deep understanding of process validation (IQ/OQ/PQ) and statistical analysis including capability, confidence/reliability, etc. to provide high level planning and execution on validation activities
• Able to evaluate short-term project and process risks and react with appropriate speed and prioritization.
• Iteratively design, fabricate, test, and implement unique/complex process fixturing and gauging.
• Support new equipment identification initiatives including selection, justification, setup and training on new or novel pieces of equipment.
• Participate as technical lead in customer visits, key contact for customer projects
• Support cost evaluation in partnership with business development and technical solutions teams.
• Support identification/research of new technologies, equipment, and capabilities for the business
• Mentor and provide guidance to NPI Engineer I, II and 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
• 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/cleanroom environment

• 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 ISO
  13485/GMP environment
• Engineering experience with medical devices
• Process design and validation
• 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 materials and related processes
• Project management experience
• Manufacturing automation, including electronic visual inspection
• Proficient in 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
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask

What's it like to work at Cretrex 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…