Sr. Manufacturing Engineer

Select Source International; Plano (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Select Source International is seeking a Sr Manufacturing Engineer to lead complex investigations and driver of continuous improvement in a plan-driven, regulated manufacturing setting in Plano, TX. The role emphasizes data-driven decision making, yield and defect reduction, and robust process implementation.

The engineer will mentor junior staff, liaise with Production, Quality, R&D, and Supply Chain, and ensure compliance with FDA, ISO, GMP requirements while delivering scalable operations.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of manufacturing engineering experience in regulated environments.
• Experience leading cross-functional investigations and CAPA.
• Strong data analysis and problem-solving skills, able to drive decisions.
• Fluent English for meetings, documentation, and presentations.

Responsibilities

• Lead troubleshooting of complex manufacturing and equipment issues to minimize downtime.
• Analyze yield, scrap, defects, and performance data to identify trends and improvements.
• Lead root cause investigations using structured methodologies (6M, 5 Why, DOE).
• Drive continuous improvement on quality, productivity, cost, and capacity.
• Coordinate CAPA with cross-functional teams and document actions.
• Plan and document validations using IQ/OQ/PQ; develop SOPs and control plans.
• Mentor junior engineers and provide technical guidance to manufacturing personnel.
• Assess automation, tooling, and process improvements for efficiency.
• Communicate project status and business impact to leadership.
• Ensure compliance with FDA, ISO, GMP and internal quality systems.

Skills

Advanced problem-solving

Data analysis

Cross-functional leadership

Root cause analysis

Communication skills

Education

Bachelor's degree in Mechanical Engineering or related

Tools

Minitab

JMP

Job description

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.

Key Responsibilities

• 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.

Must Have

• 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.

Required Experience

• 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.

Top 5 Key Skills

• 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

Preferred Experience

• 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.