Sr. Manufacturing Engineer
Listed on 2026-08-22
-
Engineering
Quality Engineering, Process Engineer, Manufacturing Engineer, Lean Manufacturing / Six Sigma
Job Summary
The Manufacturing Engineer serves as a technical leader supporting daily manufacturing operations through advanced troubleshooting, data-driven decision making, yield improvement, defect reduction, and implementation of robust manufacturing processes. This engineer independently leads complex investigations, drives cross-functional problem solving, and identifies opportunities to improve operational performance, quality, and cost.
Job Title:
Sr Manufacturing Engineer
Location:
Plano TX 75024
Duration: 12 Month
The engineer will lead the implementation and validation of new equipment, automation, and manufacturing processes utilizing the IQ/OQ/PQ framework and applicable regulatory requirements. They will partner closely with Production, Quality, R&D, Supply Chain, and other cross-functional teams to ensure compliant, efficient, and scalable manufacturing operations. The engineer is expected to serve as a subject matter expert, mentor junior engineers, and communicate technical findings and business impacts to all levels of the organization, including senior leadership.
- Lead troubleshooting of complex manufacturing, process, and equipment-related issues to minimize downtime and maintain production objectives.
- Analyze yield, scrap, defect, and process performance data to identify trends and drive sustainable improvements.
- Lead root cause investigations using structured problem-solving methodologies such as 6M, 5 Why, Fishbone, DOE, and statistical analysis tools.
- Drive continuous improvement initiatives focused on quality, productivity, cost reduction, capacity expansion, and process robustness.
- Lead cross-functional teams in the execution and implementation of corrective and preventive actions (CAPA).
- Plan, execute, and document equipment and process validations using IQ/OQ/PQ methodologies.
- Develop and optimize manufacturing processes, work instructions, control plans, and standard operating procedures.
- Provide technical mentorship and guidance to junior engineers and manufacturing personnel.
- Assess and implement automation, tooling, and process improvements to enhance operational efficiency.
- Communicate project status, technical findings, recommendations, and business impact to stakeholders and leadership.
- Ensure compliance with FDA, ISO, GMP, and internal quality system requirements.
- Excellent or native English language fluency due to all meetings, procedures, and technical communications being conducted in English.
- Demonstrated ability to influence and collaborate effectively with cross-functional teams and stakeholders at all organizational levels.
- Proven experience leading technical investigations and driving issue resolution in a manufacturing environment.
- Strong analytical and problem-solving skills with the ability to make data-driven decisions independently.
- Bachelor s degree in Mechanical Engineering (preferred), Industrial Engineering, Electrical Engineering, Chemical Engineering, Bioengineering, or related engineering discipline.
- 5+ years of manufacturing engineering experience, preferably in a regulated industry.
- Experience leading manufacturing support activities, process improvements, and cross-functional projects.
- Experience performing equipment and process validations (IQ/OQ/PQ).
- Experience utilizing structured root cause analysis methodologies and implementing corrective actions.
- Advanced technical problem-solving and troubleshooting
- Statistical data analysis and process optimization
- Cross-functional leadership and project management
- Root cause analysis and corrective action implementation
- Strong verbal, written, and presentation communication skills
- Medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing experience.
- Lean Manufacturing, Six Sigma Green Belt or Black Belt certification.
- Advanced statistical analysis using Minitab, JMP, or similar software.
- Experience with automation, robotics, vision systems, or advanced manufacturing technologies.
- MES, ERP, and manufacturing data systems experience.
- Design of Experiments (DOE), process characterization, and validation expertise.
- Experience mentoring engineers, technicians, and production personnel.
- Experience leading capital equipment implementation projects.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).