Manufacturing Engineer (Engineer Tech) Job at Thermo Fisher Scientific Inc. in M

Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) As 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. The Manufacturing Engineer owns process performance for assigned lines/cells, driving equipment validation, automation integration, and continuous improvement to meet targets for OEE, first-pass yield, scrap, cycle time, and uptime. The role delivers robust technical standard work, quality controls, and data-driven problem solving to sustain reliable, compliant, and efficient operations. This role supports operations at Thermo Fisher's state-of-the-art Mebane, NC Manufacturing Center for pipette tip production. Process Ownership and Performance * Serve as the central technical owner and hub for the manufacturing cell, including molding and automation, coordinating cross-functional activities and decisions to achieve performance targets. * Perform bottleneck analysis and ergonomic assessments; Create and maintain PFMEA, Control Plans, Process Flows, and risk-based reaction plans. * Plan and execute IQ/OQ/PQ and FAT/SAT (as applicable) aligned with process risk assessments and critical requirements. * Manage engineering changes with documented risk assessment and validation before release; prepare complete validation reports and production release packages. Quality Systems and Compliance * Execute Measurement Systems Analysis (MSA), including GR&R; maintain gauge inventory and calibration status. * Own Statistical Process Control (SPC): select chart types, set control limits, and define/react to out-of-control action plans. Partner with controls engineering to specify, integrate, and sustain sensors, actuators, conveyors, pick-and-place, vision tools, HMI updates, PLC change requests, I/O checkout, and recipe/version control. * Collaborate with controls engineers and vendors to troubleshoot root causes, implement upgrades, and improve reliability. * Collaborate with Reliability Engineering on PM optimization and predictive strategies; analyze downtime data to drive MTBF/MTTR improvements. * Develop spares planning and rationale, in conjunction with Reliability Engineering, based on criticality, usage, and lead time; Kaizen, Readiness, and Projects * Lead targeted technical Kaizen events (VSM, SMED, 5S, Visual Management, A3 problem solving) from scope to sustainment, delivering measurable gains in throughput, changeover, quality, and safety. * Define manufacturing readiness gates and exit criteria, support plant startup and smooth transition from prototype to volume. * Develop project charters, schedules, and status updates; Minitab, Power BI) to build dashboards and data-driven insights. Safety and Floor Support * drive ergonomic risk reduction. * Provide hands-on technical floor support, on-call coverage during launches, and timely Andon/escalation response. Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or related Engineering Discipline. * 2-5 years of manufacturing engineering experience * Hands-on experience with automation and controls (vision systems, sensors, conveyors, pick-and-place, HMI/PLC change process). * Strong Lean/Six Sigma toolkit (VSM, SMED, 5S, A3 problem solving, Visual Management); data analysis and statistical skills. * Excellent technical writing for standard work and validation reports; 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. 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. Mebane, NC - new state-of-the-art facility: Mebane video