Staff Process Engineer

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

Join an innovative team at Thermo Fisher Scientific, where you'll advance manufacturing excellence and contribute to impactful solutions. As a Staff Manufacturing Engineer, you'll provide technical leadership for complex manufacturing processes, equipment automation, and capital projects. You'll collaborate across multiple functions to enhance production efficiency, ensure product quality, and implement advanced technologies. This role offers the opportunity to solve complex technical challenges while supporting our mission of enabling customers to make the world healthier, cleaner and safer.

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 Root Cause Analysis (5-Why, Fishbone, Fault Tree), statistical analysis and SPC data review, and process capability and variation analysis
• Partner with Quality Engineering to define and implement containment plans, support customer-facing complaint responses, and 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 Injection Molding, Extrusion Blow Molding (Accumulator & Continuous), and Injection Blow Molding
• Define critical process parameters, controls, alarm limits, and escalation criteria
• Support development and maintenance of Control Plans, Reaction Plans, and 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 process changes, mold repairs or modifications, equipment changes or refurbishments, and 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 Process Specifications, Set-Up Sheets, Control Plans, and Work Instructions
• Ensure molding processes comply with applicable ISO standards, internal QMS requirements, and 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

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