Manufacturing Engineer II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

How will you make an impact?

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.

• 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.

Methods and Validation

• 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.

Quality Systems and Compliance

• 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.

Automation, Controls, and Reliability

• 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.

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.

• 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.

Safety and Floor Support

• 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.

Qualifications

• 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 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.

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.