Sr Manufacturing Technician

Responsibilities

• Perform advanced troubleshooting of equipment, processes, and product-related issues, ensuring minimal downtime and optimal performance.
• Conduct root cause analysis and corrective actions for recurring issues using structured problem-solving methodologies.
• Create, execute, and document engineering tests for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain and improve production equipment reliability through preventive maintenance and technical upgrades.
• Independently set up, calibrate, and validate complex manufacturing equipment and new technology introduction.
• Ensure compliance with GMP, ISO standards, and internal quality requirements.
• Lead process improvement initiatives using Lean and Six Sigma principles.
• Perform statistical analyses such as Pareto charts, line charts, trend analysis, and other data-driven evaluations to identify improvement opportunities.
• Develop and implement manufacturing aids, fixtures, and tooling to enhance efficiency and quality.
• Collaborate with engineering teams on new product introductions, process validations, and technical documentation.
• Provide technical training and mentorship to Manufacturing Technicians and production operators.
• Deliver handson training for manufacturing processes, standard work, and quality expectations.
• Support continuous improvement projects and contribute to cost reduction, yield improvement, and cycle time reduction.

Qualifications

• High School diploma or GED or equivalent
• 3+ years of experience in a manufacturing or operations technical role
• Mechanical aptitude and strong troubleshooting skills using technical and analytical thinking
• Strong oral and written communication skills
• Experience working in a medical device or GMP manufacturing environment
• Working in a class 7 cleanroom
• Knowledge of Lean Manufacturing and Six Sigma methodologies
• Ability to read and interpret engineering drawings, blueprints, and technical specifications
• Familiarity with FDA regulations and ISO 13485 standards
• Experience with process validation and equipment qualification
• Comprehension of blueprints, including basic dimensioning and tolerance
• Experience with microscope, caliper, ruler (various types), and micrometer
• Knowledge of documentation software suite, CAD software
• Ability to sit and/or stand for long periods of time
• Long periods of microscope usage
• Experience lifting up to 50 pounds
• Occasional travel for local vendor support, training, or supplier investigations

Preferred Qualifications

• Associates degree in a related field
• Proficient in Microsoft Office suite, Minitab, SolidWorks, etc
• General machining experience