Sr. Manufacturing Engineer

About the Role

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. The role involves leading the implementation and validation of new equipment, automation, and manufacturing processes using the IQ/OQ/PQ framework and applicable regulatory requirements. The engineer will partner closely with Production, Quality, R&D, Supply Chain, and other cross-functional teams to ensure compliant, efficient, and scalable manufacturing operations.

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.

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.

Qualifications

• 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.

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.