Senior Process Engineer

Job Title: Senior Process Engineer Job Description The Senior Process Engineer develops and optimizes robust injection molding processes using scientific molding techniques, leads continuous improvement initiatives, and ensures compliance with ISO and FDA medical device regulations. This role collaborates closely with quality, manufacturing, and operations teams to validate processes using sound statistical methods, maintain accurate engineering documentation, and drive effective problem-solving and root cause analysis on the production floor.

Responsibilities Develop robust injection molding processes utilizing scientific molding techniques, including gate freeze analysis, short shot analysis, and other decoupled molding methods. Collaborate with the quality team to validate injection molding processes using sound statistical methods and appropriate validation approaches such as IQ, OQ, and PQ. Maintain complete and accurate engineering files, including design of experiments (DOE) reports, process sheets, and water diagrams.

Lead continuous improvement projects focused on process optimization, quality enhancement, and operational efficiency in manufacturing engineering. Perform failure investigations using structured problem-solving techniques and statistical analysis to identify root causes and implement effective corrective actions. Author test protocols and execute validation protocols to meet ISO and FDA medical device regulatory requirements.

Verify that all documents and process records are correctly completed and approved prior to set-up sign-off on the production floor. Provide training, coaching, and technical guidance to peers and Process Technicians to support skill development and consistent process execution. Maintain and promote a safe and clean working environment, ensuring adherence to established housekeeping and safety practices.

Follow all applicable safety procedures and guidelines as outlined in the company safety manual. Support documentation activities on the manufacturing floor to ensure processes are properly recorded, controlled, and updated. Contribute to manufacturing engineering and process improvement initiatives, including the application of Lean Manufacturing concepts where appropriate. Perform other related duties as necessary to support production, quality, and engineering objectives.

Essential Skills Extensive experience with injection molding and plastic injection molding processes, including decoupled molding and scientific molding techniques. 7+ years of experience implementing decoupled molding processes and applying scientific molding methods such as gate freeze analysis and short shot analysis. Strong background in manufacturing engineering and process engineering within an injection molding environment.

Hands-on experience with process validation activities, including IQ, OQ, and PQ for medical device or regulated manufacturing. Proficiency in using sound statistical methods for process validation, data analysis, and problem-solving. Ability to lead and manage process improvement and continuous improvement projects from concept through implementation. Demonstrated skill in conducting failure investigations, identifying root causes, and implementing corrective and preventive actions.

Competence in creating, maintaining, and organizing engineering documentation, including DOE reports, process sheets, water diagrams, and floor documentation. Capability to train, coach, and mentor peers and Process Technicians in process standards and best practices. High school diploma. Secondary education related to plastics injection molding or an equivalent combination of education and hands-on molding experience.

Additional Skills & Qualifications Basic familiarity with Lean Manufacturing tools such as 5S and value stream mapping is preferred. Experience working within ISO and FDA medical device regulatory environments is highly advantageous. background in project management for manufacturing and pr