Molding Process Engineer

Job Title: Molding Process Engineer(Injection Molding, Extrusion Blow & Injection Blow Molding)Reports To: Manager, EngineeringGroup/Division: Life Sciences Solutions Group / Laboratory Products DivisionPosition Location: Rochester, NYShift: Days, with off-shift & weekend support as requiredThis is a contract role with full technical ownership and accountability for molding-related quality investigations, corrective actions, and validation activities.________________________________________Position SummaryThe Quality-Focused Molding Process Engineer serves as the primary technical liaison between Manufacturing Engineering and Quality, providing subject matter expertise in Injection Molding, Extrusion Blow Molding, and Injection Blow Molding to ensure product conformance and customer satisfaction.This role is heavily engaged in customer quality complaint investigations, CAPA execution, and systemic defect reduction, working cross-functionally to protect customers and compliance obligations. The engineer owns the technical root cause analysis for molding-related quality issues and is accountable for ensuring corrective actions are robust, validated, and sustained over time.________________________________________Key ResponsibilitiesCustomer Quality Complaints, CAPA & Risk Mitigation (Primary Focus) Act as technical lead for customer quality complaints involving molded components, processes, or materials. Lead investigations using structured, data-driven methodologies, including:o Root Cause Analysis (5-Why, Fishbone, Fault Tree)o Statistical analysis and SPC data reviewo Process capability and variation analysis Partner with Quality Engineering to:o Define and implement containment planso Support customer-facing complaint responseso Execute and document CAPAs within the QMS Ensure corrective actions address true root cause, are validated, and demonstrate effectiveness over time. Identify recurring or systemic quality risks and proactively drive preventive improvements. Support regulatory, customer, and internal audits as molding process subject-matter expert.________________________________________Process Control, Stability & Defect Reduction Develop, document, and maintain robust, capable molding processes that minimize defect opportunities. Establish and sustain stable process windows for:o Injection Moldingo Extrusion Blow Molding (Accumulator & Continuous)o Injection Blow Molding Define critical process parameters, controls, alarm limits, and escalation criteria. Support development and maintenance of:o Control Planso Reaction Planso Risk-based process monitoring strategies Drive defect reduction projects using trends from scrap, NCRs, complaints, and audit findings.________________________________________Production & Quality Support Provide on-the-floor technical support for quality-driven production issues. Lead investigations into NCRs, deviations, and out-of-spec conditions related to molding. Work closely with Manufacturing, Set-Up, Maintenance, and Tooling to correct quality escapes and process instability. Ensure rapid restoration of compliant production while maintaining required documentation and traceability.________________________________________Tooling, Equipment & Process Validation Provide technical support for existing molds, molding processes, and equipment supporting current production products that are tied to an NCM. Lead mold debug and process optimization activities to restore or improve stability, capability, and product conformance. Support and execute revalidation or requalification activities (IQ/OQ/PQ or equivalent) for:o Process changeso Mold repairs or modificationso Equipment changes or refurbishmentso Material changes impacting existing validated products Execute and support IQ/OQ/PQ for new or modified molds, processes, materials, and equipment. Ensure validations adequately demonstrate capability, repeatability, and defect prevention. Support SMED initiatives while maintaining quality and compliance requirements.________________________________________Documentation, Standards & Compliance Author and maintain quality-critical engineering documentation, including:o Process Specificationso Set-Up Sheetso Control Planso Work Instructions Ensure molding processes comply with:o Applicable ISO standardso Internal QMS requirementso Regulatory expectations Drive standardization and best practices across molding operations.________________________________________Continuous Improvement & Quality Leadership Use complaint, audit, and production data to prioritize improvement efforts. Lead Lean and continuous improvement initiatives with a quality-first mindset. Participate in Gemba walks, quality reviews, and KPI discussions. Prepare capital justification supporting defect prevention, risk reduction, and enhanced process control. Act as a visible quality advocate within Manufacturing Engineering. Exercise technical authority to recommend and implement molding process changes necessary to restore or protect compliance, in alignment with Quality and Manufacturing leadership.________________________________________Measures of Success (Optional but Expected Outcomes) Reduction in repeat molding-related customer complaints. Timely closure and demonstrated effectiveness of molding-related CAPAs. Improved process capability (Cp/Cpk) on critical quality characteristics. Reduced scrap, NCRs, and defect escapes tied to molding processes.________________________________________Minimum Requirements / QualificationsEducation & Experience Bachelor s degree in Engineering (Mechanical, Chemical, Plastics preferred); equivalent experience considered. 5 years manufacturing engineering experience in an ISO-regulated environment. Strong hands-on expertise in:o Injection Moldingo Extrusion Blow Moldingo Injection Blow MoldingQuality & Technical Expertise Proven experience supporting:o Customer complaint investigationso CAPA executiono Audit responses Strong understanding of SPC, process capability, and variation reduction. Experience working within formal QMS environments. Familiarity with validation methodologies (IQ/OQ/PQ).Professional Competencies Exceptional root cause analysis and critical thinking skills. Ability to translate complex technical findings into clear quality and customer-focused communication. Strong ownership mentality for product quality and compliance. Excellent organization, communication, and cross-functional collaboration skills. Ability to influence without direct authority.________________________________________Non-Negotiable Hiring Criteria Demonstrated experience leading manufacturing-related quality investigations. Deep technical expertise in molding processes. Evidence of successful CAPA implementation and effectiveness verification. Quality-first mindset with the ability to balance production urgency and compliance. Proven ability to work effectively across Engineering, Quality, and Operations.