Molding Manufacturing Engineer

The manufacturing engineer will work to drive injection molding projects to support new product development by identifying appropriate equipment, tooling, and manufacturing technology to meet the design intent and manufacturability requirements of products in development and defined in the new product development roadmap. In addition, this role will be responsible for reducing costs, improving productivity and product quality of existing products and processes, with a strong emphasis on Lean Manufacturing. This engineer will support the design and development of processes, equipment, and create the required documentation to transfer to manufacturing successfully. This engineer must be able to manage cross-functional teams and communicate project progress to management effectively.

The manufacturing engineer will provide technical expertise and manufacturing support for all injection molding operations personnel in the evaluation, qualification of proposed medical device designs for manufacturability and will be responsible for developing and implementing process validation protocols and reports (IQ/OQ/PQ). This role will also develop, implement, train, and monitor the effectiveness of injection molding processes and procedures to ensure compliance with FDA, cGMP, and all other applicable agency regulations.

This requires overall coordination of production, scheduling, health and safety, quality assurance, coaching and development, and continuous improvement activities within the production areas. Responsible for leading the plant in its mission to meet or exceed all our customer's expectations while meeting process metrics. The manufacturing engineer complies with policies, regulations and values for safety, quality, environmental and financial standards.

Essential Duties and Responsibilities:

· Develop and qualify injection molding processes through the means of scientific molding and mold flow simulations.

· Develop optimized and robust injection molding processes to meet product design requirements and perform process validations creating IQ/OQ/PQ protocols and reports.

· Lead design of experiments (DOE) to establish a stable and robust process that can be handed off to production personnel.

· Create the required documentation to successfully transfer equipment and processes to manufacturing.

· Provide technical advice related to plastic component material selection and part design to achieve required cost, performance, and quality requirements for new products as defined per the roadmap.

· Create project proposals to reduce cost, improve productivity, and product quality of existing products and processes.

· Inspect (FAI), install, qualify, validate, and maintain injection molding equipment, accessories, and instrumentation.

· Maintain injection molding tools and equipment in a required state of readiness as defined by management to meet the requirements of product development, manufacturing, quality assurance and regulatory compliance.

· Develop detailed training manuals and independently train production staff on machine and operations.

· Solely responsible for establishing work instructions that will drive day to day operations in injection molding.

· Audit manufacturing process by assessing process inefficiencies, safety improvements, and potential optimizations through the implementation of automation.

· Monitor all process parameters in injection molding, including driers, thermal control units, and testing equipment to ensure correct operation and performance.

· Investigate, identify root cause, and resolve product complaints related to molding defects, productivity variations including tooling, equipment, and processes.

· Solve technical and emergent issues on the manufacturing floor (part quality, machine reliability, process instability, etc.).

· Apply technical and process improvement tools: PFMEA, process mapping, Pareto charts, capability studies, design of experiments, in process verification, etc., as required.

· Create and manage die PM system, including detailed work instructions and manage on schedule completion of PM activities.

· Participate in R&D product development, supplier selection and development activities.

· Performs other duties as required.

Required Job Qualifications:

· Bachelor’s Degree or higher in material science, biomedical engineering, mechanical engineering, industrial engineering, or any other engineering discipline.

· 4+ years scientific molding technique experience in a production environment.

· Experience in tooling design, qualification, and troubleshooting.

· Experience in communicating with vendors, purchasing new equipment and injection molds.

· Minimum of 2 years related experience in an FDA/GMP regulated injection molding facility.

· Experience in applying statistical techniques such as statistical process control, design of experiments, and problem-solving techniques.

· Experience with design, review, execution, and approval of installation, operation and performance qualification protocols, and reports (IQ/OQ/PQ).

· Experience with measuring devices such as calipers, drop gauges, gauge blocks/pins, and comparators.

· Computer skills with MS-Office, AutoCAD, SolidWorks and MS-Project.

Preferred Job Qualifications:

· Experience providing training related to injection molding.

· Six Sigma or Lean Six Sigma green/yellow belt.

· Extensive knowledge of the ISO/FDA requirements for medical devices.

· Experience and competence reading and understanding drawings, specifications, and performance requirements.

· Additional class work in injection molding process.

Physical Demands:

· Performs primarily office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust.

· Physical activity includes walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 lbs.

· Must be able to drive an automobile for short and long distances.

· Use good judgement and follow procedures.

· Work under stress in a fast-paced environment.