Works on problems and projects where analysis of situations, process performance, equipment reliability, and 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 and production controls that meet company standards.

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

Additionally, this role supports production equipment activities including equipment implementation, reactivation, calibration coordination, process troubleshooting, failure mode analysis, and validation execution activities.

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, and regulatory standards (technical reports).

• Work with R&D, Design, Development, Transfer Engineers, and Operations teams to understand products and manufacturing processes.

• Support TIR-related activities, including metrics updates, failure mode tracking, investigations, and continuous improvement initiatives.

• Conduct engineering efforts to identify root cause analysis and process improvements.

• Responsible for the development and implementation of standard manufacturing methods, process improvements, and efficiency enhancements.

• Conduct engineering efforts to optimize medical component processing for manufacturing, including time studies, work standards, process flows, and process documentation.

• Conduct and document time studies to establish performance standards.

• Analyze and implement improvements to reduce product costs and improve operational efficiency.

• Provide technical support for manufacturing equipment and coordinate repair activities with the Maintenance team when required.

• Participate in the activation, reactivation, qualification, and implementation of production equipment.

• Support calibration requests and equipment calibration activities.

• Execute and support validation activities, including protocol execution and documentation review.

• Responsible for the design, development, and implementation of equipment, tooling, or fixtures that meet health, safety, environmental, and manufacturing requirements.

• Set up and validate production lines for manufacturing as applicable.

• Support product transfers and new product introductions.

• Investigate, respond to, and support resolution of quality issues.

• Build productive working relationships with Operations, Engineering, Quality, Maintenance, customers, and suppliers.

• Interpret electrical schematics, mechanical drawings, equipment documentation, and technical specifications.

• Work with automated and semi-automated manufacturing equipment.

SUPERVISORY RESPONSIBILITIES

Have supervisory responsibilities: No

Leadership: Supervise work through the planning and scheduling of work, and the review and approval of tasks.

Supervises: N/A

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 field.

• University studies in Engineering are highly desirable.

• 4 to 7 years of related experience in manufacturing, process support, engineering support, equipment support, or similar technical roles.

• Experience in the Medical Device industry is highly desirable.

• Experience working with automated or semi-automated production equipment is preferred.

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

• Intermediate personal computer skills, including electronic mail, routine database activity, word processing, spreadsheets, and graphics.

• Basic knowledge of statistics, manufacturing processes, and mechanical systems is desirable.

• Basic English proficiency is desirable. 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

• Knowledge of Quality Systems and Medical Device Regulations, including Process Validation, Traceability, Quality Systems, Risk Management, and Nonconformance Management.

• Technical skills in manufacturing processes and methods, including tooling, workflow, layout, assembly processes, and production equipment.

• Ability to become a Subject Matter Expert (SME) and train others.

• Experience supporting automated and semi-automated manufacturing equipment.

• Ability to interpret electrical schematics and mechanical drawings.

• 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.

MANUAL DEXTERITY

Manual dexterity sufficient to reach, handle items, and work with fingers.

VISION REQUIREMENTS

Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).

TRAVEL

Minimal overnight travel.

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated, and/or air-conditioned indoor office and manufacturing environment with adequate ventilation.

PHYSICAL DEMANDS

Other Physical Working Conditions

• Lifting or carrying items.

• Moderate noise (examples: manufacturing environment, business office with computers and printers).

PHYSICAL ACTIVITY LEVEL

Light physical activity performing non-strenuous daily activities of a productive and technical nature.

COMMENTS

This position 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, supporting equipment, process improvements, validation execution, production readiness, and continuous improvement initiatives. It requires strong technical knowledge, independent decision-making, and close interaction with Engineering, Operations, Quality, and Maintenance teams.