Manufacturing Engineer III (New Product Development) - Cretex Medical Component and Device Technologies

Overview

About Cretex Medical

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. Learn more at www.cretexmedical.com.

Manufacturing Engineer III Position Summary

The Manufacturing Engineer lll 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 machining, packaging, welding, assembly, and molding).
Responsibilities

Manufacturing Engineer III Duties and 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

Qualifications

Manufacturing Engineer III 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

• Project management experience
• 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

Manufacturing Engineer II Preferred Knowledge, Skills and Abilities

• Continuing Education; including participation in local chapters, associations, and/or organizations