Manufacturing Engineer II, III, Sr

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  .

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  .

The Manufacturing Engineer will be responsible for leading the manufacturing of product and implementation of improvements including cost, manufacturability, and quality goals. Responsible for planning, designing, developing, and maintaining programs, training, and manufacturing processes (such machining, packaging, welding, assembly, and molding). Provide direction and support for existing products including support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.

• Role open to Manufacturing Engineer level II/III/Sr candidate based on experience**

• Initiate and complete technical activities leading to new or improved processes or design for manufacturability for current and next generation programs and to meet strategic goals and objectives of the company
• 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
• Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues
• Maintain and approve manufacturing procedures
• Design and coordinate fabrication and implementation of process fixturing or gauging
• Resolve non-conformances and participates on Material Review Board
• 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
• Read, understand, and follow work instructions and standard work
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets we serve

• Bachelor’s Degree in Mechanical, Industrial, or other Engineering Science
• Experience
• Manufacturing Engineer II - 3 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
• Manufacturing Engineer III - 5 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
• Manufacturing Engineer Sr - 7 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions
• Experience in an ISO
  13485/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
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail and organization skills
• Ability to work in a fast-paced team environment, ability to multitask

• Continuing Education; including…