Thermo Fisher Scientific · 1 day ago
Engineer II, Manufacturing Engineering
Mebane, NC
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a global leader in scientific solutions, dedicated to making the world healthier, cleaner, and safer. The Manufacturing Engineer will own process performance for assigned lines, focusing on equipment validation, automation integration, and continuous improvement to meet operational targets. This role is crucial for ensuring reliable and efficient operations at the Mebane, NC Manufacturing Center.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
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
Own KPIs: OEE, first-pass yield, scrap rate, cycle time, changeover time, MTBF/MTTR
Maintain technical Standard Work, work instructions, routings, and line balance to meet takt and safety requirements
Perform bottleneck analysis and ergonomic assessments; implement improvements with quantified results
Create and maintain PFMEA, Control Plans, Process Flows, and risk-based reaction plans
Plan and execute designed experiments and capability evaluations; establish and sustain appropriate control charts; drive Root Cause Countermeasure (RCCM) to close issues and prevent recurrence
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
Implement Good Documentation Practices (GDP); author and maintain MCPs, deviations, NCRs, and support CAPA
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; define reorder points/quantities aligned to OEE targets
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
Participate in design reviews; perform DFM/DFA and tolerance assessments; set process capability targets before design freeze
Define manufacturing readiness gates and exit criteria, support plant startup and smooth transition from prototype to volume
Develop project charters, schedules, and status updates; perform cost-benefit and business case analysis for CI and capital proposals
Use MES/ERP for routings/BOMs, CMMS for maintenance tasks, and analysis tools (e.g., Minitab, Power BI) to build dashboards and data-driven insights
Conduct Job Safety Analysis (JSA), ensure machine guarding compliance, and establish LOTO procedures; drive ergonomic risk reduction
Provide hands-on technical floor support, on-call coverage during launches, and timely Andon/escalation response
Qualification
Required
Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or related Engineering Discipline
2–5 years of manufacturing engineering experience
Proficiency in PFMEA, Control Plans, DOE, SPC, MSA (GR&R), and validation (IQ/OQ/PQ)
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; effective cross-functional communication
Preferred
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)
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
2026-01-09
EIN Presswire
2026-01-07
Company data provided by crunchbase