NPI Engineer II

Cretex • Brooklyn Park, MN

1d • Onsite

About The Position

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Their customers view them as a trusted partner in the areas of injection molding, laser processing, metal stamping, and device assembly. The NPI Engineer ll will be responsible for the development, validation, and launch of new products into the production environment. This position will also be responsible for designing, validating, and developing new products while working through a defined stage gate process, and will provide training and support to operators and technicians on NPI programs and launches.

Requirements

• 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 ISO13485/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.).

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 401k retirement savings plan with a company match contribution
• Onsite health clinics
• Discretionary holiday bonus program (based on years of service)
• Cretex University
• 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost
• Wellness program with incentives
• Employee death benefit
• Employee sick and safe leave
• Comprehensive medical insurance with access to virtual providers
• Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider)
• Vision insurance
• Pre-tax health savings account
• Healthcare and dependent care pre-tax reimbursement accounts
• Paid holidays
• Paid time off
• Discretionary profit sharing program
• Parental Leave
• Accident and critical illness benefits
• Optional employee, spouse, and child life
• Short and long term disability
• Company provided life insurance
• Tuition assistance programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees