Thermo Fisher Scientific

Manufacturing Engineer II

Thermo Fisher Scientific • $75K — $95K *
Mebane, NC 27302In-Person
Manufacturing & Automotive
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or related 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, including vision systems and PLC processes.
  • Strong Lean/Six Sigma toolkit; skilled in data analysis and statistical methods.
  • Excellent technical writing and cross-functional communication skills.

Responsibilities

  • Drive performance targets for OEE, first-pass yield, scrap, cycle time, and uptime.
  • Act as the technical owner for the manufacturing cell and coordinate cross-functional activities.
  • Maintain technical standard work, work instructions, and safety requirements.
  • Conduct bottleneck analysis and ergonomic assessments for process improvements.
  • Plan and execute validation and capability evaluations aligned with risk assessments.
  • Implement Good Documentation Practices and manage quality controls.
  • Lead technical Kaizen events to improve throughput, quality, and safety.

Benefits

  • Standard Monday to Friday work schedule.
  • Opportunities for hands-on technical support and comprehensive training.
  • Exposure to advanced manufacturing technology and processes in a state-of-the-art facility.
  • Involvement in cross-functional project teams for continuous improvement initiatives.
Full Job Description
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

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).


About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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