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 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 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 REQUIREMENTS 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 Injection Molding, Extrusion Blow Molding, and Injection Blow Molding Quality & Technical Expertise Proven experience supporting customer complaint investigations, CAPA execution, and 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 Compensation and Benefits The salary range estimated for this position based in New York is $103,100.00–$154,700.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: