Process Engineer

Overall responsible to develop and implement stable molding processes and controls to assure consistency on parts and meet quality standards. Maximize process efficiencies and support the Plastics manufacturing activity as well as various secondary processes. Perform mold validations. Investigate and resolve work-in-process problems. Contact suppliers in the process of correcting equipment problems. Support the Engineer, Production and Program manager team. Be self-motivated and implement a Teamwork environment.

Essential Job Functions and Responsibilities:

• Develop, design and setup robust molding processes utilizing scientific and decoupled molding, by running SMPD, DOEs, OQs, and PQs run.
• Create documentation of molding set-ups, processes, and workflows.
• Quantify current process capabilities as a foundation for evaluating and improving processes and products.
• Improve production efficiencies by improving cycle times, reducing scrap, improving setup time, workstation layout and yield, by implementing cGMP.
• Troubleshoot defects and trace to the root cause to determine how to change the process or the mold to eliminate the future occurrence.
• Audit processes to verify documented process match actual process being used.
• Ensure Setup and Process Techs are processing jobs correctly.
• Maintain up to date the “Part Number Info” in the database.
• Answers customer complaints and implements corrective action when necessary to resolve issues.
• Provide advanced engineering support in the areas of design, manufacturing process, material characteristics related to the development and manufacture of the product.
• Lead process improvement team using modern manufacturing tools and methods, e.g., Lean, Kaizen, Six Sigma, cGMP, etc.
• Coordinate mold validations and tests with scheduling, molding, tool room, and quality department. Evaluate each process for automation, cycle efficiencies, and reduction of labor.
• Work with the tool room to improve manufacturing capabilities of new and existing tooling.
• Train and assist with mentoring of Process Technicians, Setups and key operations personnel to develop and enhance process knowledge and skills.
• Work with Engineering, Production, Quality and Maintenance groups to establish, execute and monitor preventive maintenance programs.
• Work with the Program manager as support to meet project deadlines.
• Lead, participate in, or support continuous improvement activities.
• Work with vendors and suppliers, customers and other outside technical resources to develop and improve manufacturing methods that contribute to the reduced product cost and improved product performance.
• Work with Internal and External customers during product development to assure the product meets part print and function.
• Work close with Tool development Engineer, Tool Room Manager, Production Manager, Maintenances Manager and Quality Manager to maintain a teamwork environment
• Ensure safe work environment and participate fully in Safety programs.

Core Competencies:

• General Safety
• IQMS Knowledge
• Electrical Equipment Operation
• Document and Records Control
• Compliance Management
• BluePrint Reading
• Customer Service (internal or external)

Knowledge, Skills, and Abilities

· Awareness, agreement and advancement of company values and goals

· Advanced level knowledge of engineering plastics, resins, and polymers.

· Good verbal, written communication, and presentation skills and the ability to interface within a cross-functional team environment.

• Extensive knowledge of injection molding machines and accessory equipment (robots, grinders, water systems/water treatment) a must.
• Must have mechanical skills. Must be able to read part prints and use measuring equipment (calipers, comparators, etc.).
• Must have good communication and basic computer skills.
• Must have in-depth knowledge of multi-component molding, design of experiments, basic statistics, insert molding, mold-flow analysis, and various types of process monitoring tools and techniques.
• Preferred to have experience and knowledge in Statistical Process Control (SPC) principles, Multi-variable Analysis (MVA), and various types of injection molding process data collection/analysis systems.

Education and/or Experience :

• Bachelor of Science or equivalent experience required experience
• More than 5 years of engineering experience in a Medical manufacturing environment.
• RGJ Master Molder 1 Certification required.
• RGJ Master Molder 2 (desired not required).
• FimmTech Certification (desired not required).