Molding Process Engineer

Job Title: Molding Process Engineer
(Injection Molding, Extrusion Blow & Injection Blow Molding)
Reports To: Manager, Engineering
Group/Division: Life Sciences Solutions Group / Laboratory Products Division
Position Location: Rochester, NY
Shift: Days, with off-shift & weekend support as required

This is a contract role with full technical ownership and accountability for molding-related quality investigations, corrective actions, and validation activities.

Position Summary
The 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 Responsibilities
Customer 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 review
o Process capability and variation analysis
• Partner with Quality Engineering to:
o Define and implement containment plans
o Support customer-facing complaint responses
o 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 Molding
o 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 Plans
o Reaction Plans
o 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 changes
o Mold repairs or modifications
o Equipment changes or refurbishments
o 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 Specifications
o Set-Up Sheets
o Control Plans
o Work Instructions
• Ensure molding processes comply with:
o Applicable ISO standards
o Internal QMS requirements
o 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 / Qualifications
Education & 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 Molding
o Extrusion Blow Molding
o Injection Blow Molding
Quality & Technical Expertise
• Proven experience supporting:
o Customer complaint investigations
o CAPA execution
o 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.