NPI Engineer Sr

Cretex • Brooklyn Park, MN

3d

About The Position

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 stampi ng and device assembly . Learn more at www.cretexmedical.com . Position Summary: The Senior NPI Engineer 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 leadership to the NPI organization to support department initiatives, provide mentorship, and support cross functional projects between NPD, Quality, and Manufacturing.

Requirements

• Bachelor’s Degree in Mechanical, Industrial, or other Engineering Science
• 7 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
• Demonstrated engineering field of expertise such as mechanical, electrical, biomaterials, etc.
• Manufacturing process design and validation
• Manufacturing equipment and fixture/gauge design
• Lean manufacturing training skills
• Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)
• Ability to solve a wide range of moderately complex engineering problems in creative and practical ways
• Manage projects of high complexity
• 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
• Detail oriented; checks own work, keeps accurate records, organizes information effectively
• Ability to tolerate ambiguity, multiple priorities and short deadlines

Nice To Haves

• Master’s Degree in an Engineering discipline
• Continuing Education; including participation in local chapters, associations, and/or organizations

Responsibilities

• Initiate and complete technical activities leading to new 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 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 providing risk-based feedback to meet both quality and customer timeline requirements.
• Deep understanding of process validation science (IQ/OQ/PQ) and statistical analysis including capability, confidence/reliability, etc. to provide high level planning of activities and drive validation improvements.
• Able to evaluate short and long-term project and process risks and react with appropriate speed and prioritization.
• Provide leadership for projects within function.
• Iteratively design, fabricate, test, and implement unique and complex process fixturing/gauging.
• Support new equipment identification initiatives including selection, justification, setup and training on new or novel pieces of equipment.
• Participate as subject matter expert in customer visits, key contact for customer projects.
• Support early-stage project evaluation and part cost evaluation in partnership with business development and technical solutions teams.
• Mentor and provide guidance to Manufacturing Engineer I, II, III, and Engineering Technicians.
• Interface with Quality, Development, and Manufacturing organizations to integrate new products or processes into the existing production area and drive improvement cross-functionally.
• Ensure business systems are implemented, maintained, and function properly and identify areas of improvement.
• Subject matter expert in multiple areas for process engineering.
• Collaborates closely with management, providing technical insights for business strategies.
• 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.

Benefits

• 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
• an employee death benefit
• employee sick and safe leave are available to all Cretex employees.
• 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
• a pre-tax health savings account
• healthcare and dependent care pre-tax reimbursement accounts
• paid holidays
• paid time off
• our discretionary profit sharing program are available to employees working 20+ hours/week.
• 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 are available to employees working 30+ hours per week.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level