Description

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionThermo Fisher - MebaneJob DescriptionJob Profile: Manufacturing Engineer IIIJob Code: OPS.MFGE.P06Business Title: Manufacturing Engineer IIIAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.How will you make an impact?Own end-to-end performance of high-throughput molding/automation cells or lines with minimal oversight. Set technical direction, lead cross-functional execution, and deliver measurable gains in OEE, FPY, scrap, cycle time, changeover, MTBF/MTTR, and uptime. Shape capacity and capital strategies; manage multiple projects from scope to sustainment.Automation, Controls, and Reliability• Specify, integrate, and sustain sensors, actuators, conveyors, pick-and-place, and vision systems; drive HMI updates and PLC change requests with proper version/recipe control and I/O checkout.• Lead troubleshooting of chronic automation faults; implement upgrades using downtime Pareto and failure-mode data.• Optimize PM/predictive maintenance with Reliability Engineering; analyze CMMS data to increase MTBF and reduce MTTR.• Define critical spares strategy (criticality, usage, lead time); set reorder points aligned to OEE targets.• Implement error-proofing, interlocks/Jidoka, and inline vision to prevent defects and protect equipment.Process Methods, Validation, and Quality• Author and maintain PFMEA, Control Plans, Process Flows, and reaction plans; define and achieve process capability targets.• Execute DOE, capability studies, SPC, and RCCM/8D; reduce OOC events and prevent recurrence.• Lead IQ/OQ/PQ and FAT/SAT; deliver audit-ready validation packages and controlled production release.• Manage ECN/ECO with risk assessment and required revalidation.• Ensure GDP, manage MCPs, deviations, NCRs, and close CAPAs with verified effectiveness.• Own MSA (GR&R); maintain gauge inventory and calibration.New Product Introduction (NPI) and DFM/A• Act as manufacturing lead for NPI, owning industrialization from pilot through ramp. Define manufacturing requirements, automation concepts, and process capability targets aligned to product CTQs.• Drive DFM/DFA with product engineering; perform tolerance stack-ups and manufacturability reviews; influence design to meet yield, cycle time, and cost goals.• Plan and execute process qualifications, capacity validation, and ramp-to-rate; coordinate tooling/fixture/automation readiness, FAT/SAT, and IQ/OQ/PQ.• Establish production control plans, standard work, training, and spare strategies before launch; stabilize post-launch with data-driven improvements.Operations Excellence and Projects• Maintain and improve technical Standard Work, work instructions, routings/BOMs, and line balance to meet takt and safety.• Build performance dashboards from MES/ERP and CMMS; drive daily management and action logs.• Lead kaizen (VSM, SMED, 5S, Visual Management, A3) delivering quantified throughput, changeover, quality, and safety gains.• Define readiness gates and exit criteria; develop charters, schedules, risks, and business cases; ensure benefits realization.Leadership, Collaboration, and Autonomy• Operate independently on ambiguous automation/process challenges; define approach, timeline, and success metrics; proactively mitigate risks.• Act as technical hub for assigned assets across operations, quality, reliability, supply chain, EHS, and vendors; represent Manufacturing in audits and reviews.• Mentor Engineers I–II and technicians; review standard work and validation for rigor; establish best practices and training for automation operations and troubleshooting.Qualifications• Bachelor’s in Manufacturing, Mechanical, Industrial Engineering, or related.• 5–8 years in automated/high-throughput manufacturing with proven OEE/FPY improvements and scrap, cycle time, changeover, and reliability gains.• Proficient in PFMEA, Control Plans, DOE, SPC, MSA, IQ/OQ/PQ; strong technical documentation.• Hands-on with automation/controls (vision, sensors, conveyors, pick-and-place, HMI/PLC change control) and production troubleshooting.• Lean/Six Sigma (VSM, SMED, 5S, A3, Visual Management); tools: MES/ERP, CMMS, CAD, Minitab, Power BI.• Strong cross-functional influence and vendor/integrator management.• Excellent technical writing for standard work and validation reports; effective cross-functional communication. Preferred Qualifications • High-volume production experience in life sciences, injection molding, clean room, or regulated/heavily automated industries. • Proven track record of improving manufacturing performance using statistical methods and lean tools. • Certification(s): Lean Six Sigma Green Belt, CMfgE. • Experience with MES/ERP, CMMS, CAD and data tools (Minitab, Power BI). Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.