NPI Engineer II

About the role

The NPI Engineer ll will be responsible for the development, validation, and launch of new products into the production environment. This position will also provide training and support to operators and technicians on NPI programs and launches.

Responsibilities

• 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.
• Develop, 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.
• Contribute to risk documents such as pFMEAs and MVPs.
• Understand process validation (IQ/OQ/PQ) and statistical analysis including capability, confidence/reliability, etc. to support execution and documentation of validation activities.
• Iteratively design, fabricate, test, and implement process fixturing and gauging.
• Support set-up, training, and setting development on new or novel pieces of equipment.
• Support set-up, training, and setting development on new or novel pieces of equipment.
• 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.
• 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.

Requirements

• 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 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.).

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).

Benefits

• USD $75,000.00 - USD $112,600.00 /Yr.
• Our 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.
• 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.