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 i s required.

Experience supporting process validations, equipment qualifications, process improvements, manufacturing engineering activities, or equipment lifecycle activities is strongly preferred.

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.