Job Description

SUMMARY: Working under little to no supervision and following detailed verbal, written, and hands-on instructions. Manage a team of operators to meet productivity and quality goals by performing the following duties.

SCHEDULE: Mixto Lunes - Sabado Turno B

HOURS: Lunes a Viernes de 3:25 p.m. - 9:55 p.m y sábados de 7:00 a.m. – 3:00 p.m.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• 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 the best engineering practices, company procedures, and regulatory requirements (technical reports).

• Work with R&D/Design/Development/Transfer Engineers or Customers to understand the products to be produced.

• Responsible for cost effective manufacturing product/lines through the management of yield, material usage (BOM and consumables).

• Conducts engineering efforts to identify root cause analysis.

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

• Conducts engineering efforts to optimize medical component processing for manufacturing (time studies, working standards, process flows, etc).

• Conducts and documents time studies to establish performance standards.

• Analyzes and implements improvements to reduce product costs.

• Responsible for design/development of equipment, tools or fixtures that meets health, safety and environmental standards set by the company for manufacturing methods.

• Setups and validates production lines for manufacturing as applicable.

• Supports or leads product transfers, and new product introductions

• Builds business relationship with customer and/or suppliers.

• Investigate, respond and solve quality issues, or provides supports for that process as required.

• Other duties may be assigned.

Supervision:

Immediate supervision: receive close supervision related to specific work activities, assignments, methods, usually receive frequent surveillance over job activities; instructions are detailed and assignments are typical short-term.

EDUCATION and/or EXPERIENCE: Technical degree in engineering or related; and 2-3 years of related experience and/or training. Basic personal computer skills including electronic mail, word processing, spreadsheet and graphics.

SKILLS AND COMPETENCES

• Knowledge on Quality and Medical Regulations: focus Process Validation, traceability, manage or quality issues, risk management (Required).

• Technical skills in manufacturing processes and methods including tooling, workflow, layout, assembly and production equipment. Is able to become a SME and is able to train others (Required).

• OPEX -Basic Quality Tools: 5S, Kaizen, Pareto, Ishikawa, Control Charts, Checklist, Histograms (Required).

• Provides updates in a structured manner.

• Ability to work under pressure.

• Teamwork.

• Accountability.

• Attention to detail.

MANUAL DEXTERITY: Manual dexterity sufficient to reach/handle items, works with the fingers, and perceives attributes of objects and materials.

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

ENVIRONMENTAL WORKING CONDITIONS: Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.