Senior Manufacturing Technician (Turno A)

Job Description:

Works on problems and projects where analysis of situations, process performance, equipment reliability, manufacturing issues, and production data requires review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate actions in order to develop, implement, improve, and sustain manufacturing processes, equipment performance, and production controls that meet company and regulatory requirements.

Participates in decisions within the scope of work and may provide technical guidance and mentorship to lower-level personnel. Works closely with Operations, Quality, Maintenance, Engineering, Validation, and Manufacturing teams to support process improvements, equipment qualification, production readiness, troubleshooting activities, calibration coordination, validation execution, and continuous improvement initiatives.

This role serves as a senior technical resource within the manufacturing organization and provides hands-on support for automated and semi-automated production equipment, process optimization, equipment implementation, qualification activities, failure investigations, and manufacturing readiness activities in a regulated Medical Device environment.

WORK SCHEDULE / HOURS: Shift A Monday – Friday 6:00 a.m. – 3:30 p.m.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for ensuring personal and company compliance with local and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.
• Properly document activities in accordance with engineering best practices, company procedures, validation requirements, GDP standards, and regulatory requirements through technical reports and supporting documentation.
• Work with R&D, Design, Development, Transfer Engineers, Operations, Quality, and Validation teams to understand products, manufacturing processes, and production equipment requirements.
• Support TIR-related activities including metrics updates, failure mode tracking, investigations, corrective actions, and continuous improvement initiatives.
• Conduct root cause analysis and troubleshooting activities involving manufacturing processes, production equipment, and operational issues.
• Support failure investigations to identify root causes and implement corrective and preventive actions.
• Responsible for the development and implementation of standard manufacturing methods, process improvements, and efficiency enhancements.
• Conduct engineering efforts to optimize medical device manufacturing processes, including time studies, work standards, process flows, process documentation, and operational improvements.
• Conduct and document time studies to establish performance standards.
• Analyze and implement improvements to reduce product costs and improve operational efficiency.
• Provide hands-on technical support for manufacturing equipment and coordinate repair activities with Maintenance when required.
• Support troubleshooting activities involving mechanical, electrical, pneumatic, electromechanical, automated, and semi-automated manufacturing systems.
• Participate in equipment setup, startup, activation, reactivation, qualification, implementation, and changeover activities.
• Coordinate and support equipment calibration activities to ensure manufacturing equipment remains compliant with applicable standards and requirements.
• Execute and support validation activities, including protocol execution, documentation review, data collection, and validation reporting.
• Support Equipment Qualification and Process Validation activities including IQ, OQ, and PQ execution.
• Responsible for the design, development, and implementation of equipment, tooling, fixtures, and process improvements that meet health, safety, environmental, quality, and manufacturing requirements.
• Set up and validate manufacturing production lines as applicable.
• Support product transfers and new product introduction (NPI) activities.
• Investigate, respond to, and support resolution of quality issues and nonconformances.
• Support engineering projects focused on equipment performance, process reliability, operational excellence, and manufacturing readiness.
• Build productive working relationships with Operations, Engineering, Quality, Maintenance, customers, suppliers, and cross-functional teams.
• Interpret electrical schematics, mechanical drawings, manufacturing documentation, technical specifications, and work instructions.
• Work with automated and semi-automated manufacturing equipment.
• Act as a Subject Matter Expert (SME) for assigned manufacturing equipment, processes, or technical systems.
• Provide technical guidance and training support to operations personnel when required.

SUPERVISORY RESPONSIBILITIES

• Leadership: Provides technical leadership through planning, coordination, scheduling, and technical guidance of assigned activities.

• SUPERVISION: Receives guidance with respect to general objectives. In the majority of tasks and projects assigned, determines methods, work sequence, scheduling, and how to achieve assignment objectives while operating within specific policy guidelines.

EDUCATION AND/OR EXPERIENCE

• Technical degree in Engineering, Electromechanical Technology, Electronics, Mechanical Technology, Industrial Maintenance, Manufacturing Technology, or a related technical field.
• 4 to 7 years of experience supporting manufacturing operations, production equipment, process support, manufacturing engineering support, equipment support activities, or similar technical roles.
• Medical Device industry experience is required.
• Experience supporting FDA-regulated and ISO 13485 manufacturing environments is required.
• Experience supporting Medical Device manufacturing lines is required.
• Experience supporting automated and semi-automated production equipment is required.
• Experience performing equipment troubleshooting involving mechanical, electrical, pneumatic, and electromechanical systems is required.
• Experience supporting process validations, equipment qualifications, process improvements, manufacturing engineering activities, or equipment lifecycle activities is strongly preferred.
• Hands-on experience supporting or executing:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Equipment Qualification
• Process Validation
• Equipment implementation, startup, or reactivation activities
• Experience coordinating or supporting equipment calibration activities in regulated manufacturing environments is strongly preferred.
• Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheets, and graphics.
• Basic knowledge of statistics, manufacturing processes, quality systems, and mechanical systems is desirable.
• Basic English proficiency is required. The position requires the ability to read and understand validation documentation, review technical documents, and perform basic written updates or corrections in English when required.

SKILLS AND COMPETENCIES

Quality Systems & Regulatory Knowledge

Working knowledge of:

• FDA Regulations
• ISO 13485
• GMP (Good Manufacturing Practices)
• GDP (Good Documentation Practices)
• Process Validation
• Traceability Requirements
• Risk Management
• CAPA Systems
• Nonconformance Management
• Equipment Qualification

Manufacturing & Technical Competencies

• Strong troubleshooting skills in manufacturing environments.
• Ability to diagnose and resolve mechanical, electrical, pneumatic, and equipment-related issues.
• Experience supporting Medical Device production lines.
• Ability to interpret technical drawings, electrical schematics, mechanical drawings, work instructions, and process documentation.
• Experience with equipment setup, changeovers, qualification, installation, startup, and preventive maintenance activities.
• Experience supporting calibration activities.
• Familiarity with process validations, engineering studies, and data collection activities.
• Experience supporting high-volume manufacturing operations.
• Strong understanding of GDP requirements.
• Ability to identify failure modes, perform root cause investigations, and support corrective actions.
• Proficient in the use of measurement and inspection equipment.
• Ability to support engineering projects and continuous improvement initiatives.
• Technical skills in manufacturing processes and methods, including tooling, workflow, layouts, assembly processes, and production equipment.
• Ability to become a Subject Matter Expert (SME) and train others.
• Experience supporting automated and semi-automated manufacturing equipment.
• Knowledge of calibration processes and equipment lifecycle activities.
• Familiarity with validation execution and manufacturing documentation.
• Knowledge of statistical tools and basic data analysis techniques.

• OPEX / Basic Quality Tools

• 5S
• Kaizen
• Pareto Analysis
• Ishikawa (Fishbone)
• Control Charts
• Checklists
• Histograms

• Additional Competencies

• Ability to provide structured updates and technical reports.
• Strong analytical skills.
• Ability to work under pressure.
• Teamwork and collaboration.
• Accountability and ownership.
• Attention to detail.
• Excellent problem-solving skills.
• Ability to organize, prioritize, and manage multiple tasks simultaneously.
• Ability to read and understand technical and validation documentation in English.
• Ability to perform basic written corrections or updates to validation documents.
• Familiarity with technical terminology used in manufacturing, validation, and engineering environments.

COMMENTS

This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments, and less significant responsibilities.

This role serves as a senior technical resource within the manufacturing organization and is expected to operate with a level of technical ownership similar to a Technical Lead or Subject Matter Expert (SME), without direct people management responsibilities.

The position supports manufacturing equipment, validation execution, troubleshooting, equipment qualification, production readiness, calibration activities, technical documentation, process improvements, and continuous improvement initiatives.

Success in this position requires a strong combination of Medical Device manufacturing experience, equipment support expertise, validation execution, troubleshooting capability, technical documentation skills, and the ability to collaborate effectively with Operations, Engineering, Quality, Maintenance, and Validation teams.