Job Title: Molding Process Engineer
Location: Rochester, NY 14625
Duration: 12-Month Contract
About the Role:
We are seeking an experienced Molding Process Engineer with expertise in Injection Molding, Extrusion Blow Molding, and Injection Blow Molding to support manufacturing quality initiatives in a highly regulated environment. This role provides full technical ownership of molding-related quality investigations, corrective actions, process validations, and continuous improvement efforts.
Key Responsibilities:
• Lead customer quality complaint investigations involving molded components, materials, and manufacturing processes.
• Conduct root cause analysis using 5 Why Analysis, Fishbone (Ishikawa) Diagrams, and Fault Tree Analysis.
• Analyze SPC data, process capability studies, and variation trends.
• Partner with Quality Engineering to develop and implement containment actions.
• Support customer-facing quality responses and investigation reports.
• Execute and document CAPAs within the Quality Management System (QMS).
• Verify corrective action effectiveness and ensure sustainable solutions.
• Identify recurring quality issues and drive preventive improvement initiatives.
• Serve as the molding process subject matter expert during internal, customer, and regulatory audits.
• Provide technical expertise in Injection Molding, Extrusion Blow Molding, and Injection Blow Molding.
• Support validation activities including IQ, OQ, and PQ protocols.
• Drive process optimization and variation reduction initiatives.
• Collaborate with Engineering, Quality, and Operations teams to improve product quality and manufacturing performance.
Required Qualifications:
• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Plastics Engineering, or a related field (equivalent experience considered).
• Minimum 5 years of manufacturing engineering experience in an ISO-regulated environment.
• Strong hands-on experience with Injection Molding, Extrusion Blow Molding, and Injection Blow Molding.
• Experience leading manufacturing-related quality investigations.
• Proven experience with customer complaint investigations, CAPA execution, effectiveness verification, and audit support.
• Strong knowledge of SPC, Process Capability Analysis, Variation Reduction Techniques, QMS, and IQ/OQ/PQ Validation Methodologies.
Professional Skills:
• Excellent root cause analysis and problem-solving abilities.
• Strong verbal and written communication skills.
• Demonstrated ownership of product quality and regulatory compliance.
• Strong organizational and project management skills.
• Ability to influence and collaborate across cross-functional teams.
Non-Negotiable Requirements:
• Demonstrated experience leading manufacturing-related quality investigations.
• Deep technical expertise in molding processes.
• Proven success implementing and validating CAPA solutions.
• Quality-first mindset with the ability to balance compliance and production priorities.
• Strong collaboration experience across Engineering, Quality, and Operations teams.