• 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.

Pay Range-$40 to $45 

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.