Manufacturing Engineer II

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 Fishers 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

• Bachelors degree in Manufacturing Mechanical Industrial Engineering or related Engineering Discipline.

• 25 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 100000 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.