Manufacturing Engineer III - New Product Development

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 stamping and device assembly. The Manufacturing Engineer III is responsible for leading the manufacturing process development of new products and implementation of new manufacturing processes. This position will also be responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes such as machining, packaging, welding, assembly, and molding.

Responsibilities

• Supports new product development team within Cretex Medical - working on projects that are aimed on bringing in new technology and manufacturing solutions to Cretex Medical
• Responsible for creating manufacturing solutions for new projects either customer driven or internally driven
• Interface with external and internal stakeholders of the project and take ownership of providing timely project updates, communicating schedule, risks, or delays
• Owner of process flow and implementation of all processes required for assigned project/product
• Support implementation of new technology to Cretex Medical - may include vendor selection, equipment ordering, IQ/SAT, process development, and training
• Write Technical reports summarizing builds as well as maintain applicable work instructions
• Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology
• Interface with quality and manufacturing to integrate new products or processes into the existing production area
• Maintain and approve device routers and bill of materials
• Maintain and approve manufacturing procedures
• Design and coordinate fabrication and implementation of process fixturing or gauging
• Analyze and map processes, assesses efficiency, and implements complex project activities
• Assist with part cost estimation
• Mentor Engineer I and II
• Support and comply with the company Quality System, ISO, and medical device requirements

Requirements

• 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 ISO13485/GMP environment
• Engineering experience with medical devices
• Manufacturing process design and validation
• Manufacturing 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 statistical software
• Knowledge of materials and related processes
• Manufacturing automation, including electronic visual inspection
• 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)

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
• 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 insurance
• Short and long term disability
• Company provided life insurance
• Tuition assistance programs