Key Responsibilities

Support design transfer and process transfer activities for lithium-ion battery manufacturing
Provide engineering support and lead troubleshooting activities on the production line; perform systematic and documented Root Cause Analyses and implement corrective actions
Analyze process data to identify opportunities to reduce failures, improve yields, and enhance process performance
Participate in design reviews and pre-validation assessments of new products and processes; ensure appropriate process controls and documentation are in place
Collaborate with Product Development teams to support design transfer activities and ensure alignment with internal procedures and applicable regulatory requirements
Verify that equipment, instrumentation, and software remain in a validated and compliant state
Review proposed changes by conducting risk assessments and evaluating verification/validation approaches and documentation
Develop and support sampling plans and perform data analysis for design verification, test methods, and incoming inspection activities
Communicate results clearly to stakeholders and support data-driven decision-making on critical process issues
Coordinate with cross-functional teams to meet project timelines and balance cost, schedule, and performance considerations
Support continuous improvement initiatives across manufacturing and quality processes
Perform other duties as assigned


Qualifications

Bachelor’s (B.S.) or Master’s (M.S.) degree, preferably in a scientific or engineering discipline
Strong analytical, planning, and organizational skills
Technical and administrative capability to execute routine job responsibilities
Excellent written and verbal communication skills with the ability to collaborate effectively across teams
Strong problem-solving skills and attention to detail
Self-starter with the ability to work independently and adapt to changing priorities
Ability to mentor team members in technical qualification/validation activities


Experience

Minimum of eight (3) years of relevant experience in a regulated manufacturing environment (e.g., AS9100D or ISO 9001)
Experience in lithium-ion battery manufacturing preferred
Familiarity with industry standards and regulatory expectations (ISO, AS9100D)
Understanding of design control principles
Knowledge of statistical methods for quality analysis and process improvement


Working Conditions

Manufacturing environment (may include cleanroom and dry room conditions)
Standing for extended periods
PPE required (gloves, goggles, ESD gear)


Physical Requirements

Capable of standing and walking for extended periods
Must be able to bend, squat, reach, and climb on a frequent basis
Must be able to lift, pull and push up to 35lbs