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Packaging Engineering II

confluentmedical

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Location
Alajuela, Costa Rica
Type
Full-time
Department
Engineering
Education
Bachelor
Source
Workday

Description

Job Description:

Summary

Works on the development of packaging and labeling processes for Medical Finished Devices where sterility integrity is a primary objective. Evaluates and assesses customer requirements, regulatory requirements, and applicable international standards (ISO and ASTM) to develop, implement, and sustain compliant packaging and labeling manufacturing processes.

Responsible for the execution of Customer Change Notifications (CCN) and Supplier Change Notifications (SCN), including assessments, implementation activities, and validation requirements. Ensures compliance with the Confluent Quality System and follows phase-gate project methodologies when applicable.

Provides solutions to moderately complex technical problems, leads projects of broad scope, and may provide technical guidance and leadership to lower-level personnel. Maintains constant communication with customers and suppliers to define validation strategies and project execution timelines.

Work Schedule / Hours:  Adm. Monday to Friday 8:00 a.m. – 5:00 p.m.

Essential Duties and Responsibilities

Include the following. Other duties may be assigned.

  • Coordinate packaging and labeling activities and resources to support transfer, process development, and sustaining projects simultaneously.

  • Provide coaching and guidance to Packaging Engineers and Packaging Engineering Technicians.

  • Serve as a subject matter expert in packaging and labeling regulations including, but not limited to:

    • ISO 13485

    • ISO 11607-1

    • ISO 11607-2

    • ASTM F88

    • ASTM F1886

    • ASTM F1114

    • ASTM D4169

    • ASTM D4332

    • ASTM F1980

  • Define project plans and execution strategies to meet customer and supplier requirements while maintaining compliance and supporting business objectives.

  • Independently perform requirements assessments based on customer and supplier specifications.

  • Participate in the design, development, and testing of tooling and fixtures used in packaging and labeling processes.

  • Set up and validate packaging and labeling production lines at receiving manufacturing sites.

  • Properly document activities in accordance with engineering best practices, company procedures, and regulatory requirements.

  • Manage daily operator activities during validation activities to ensure training and execution are completed according to schedule.

  • Ensure operators comply with all company policies and procedures related to labeling and packaging activities.

  • Develop packaging and labeling processes following the Product Development Path methodology.

  • Create, review, revise, and maintain packaging and labeling documentation to ensure continuous improvement and compliance with applicable regulations.

  • Execute SCN/CCN initial assessments to determine project feasibility.

  • Perform implementation assessments involving all business functions impacted by changes.

  • Define and manage SCN/CCN governance models with customers and suppliers.

  • Apply structured problem-solving methodologies to identify root causes of non-conformances and drive continuous improvement initiatives.

  • Ensure compliance with company safety, quality, and regulatory policies and procedures.

  • Conduct pre-validation assessments to evaluate project feasibility related to cost, timeline, quality, and regulatory requirements.

  • Conduct experiments, collect and analyze data, execute First Article Inspection (FAI) activities, and prepare validation reports with minimal supervision.

  • Set up, adjust, and operate laboratory and manufacturing equipment used in packaging and labeling development and validation activities.

Supervisory Responsibilities

Leadership

  • Yes

Direct Reports

  • Packaging Engineering Technician I

  • Packaging Engineering Technician II

  • Packaging Engineer I

  • Packaging Engineer II

Supervision

Receives guidance regarding overall objectives; independently determines methods, work sequence, scheduling, and approaches for achieving assigned goals while operating within established company policies and procedures.

Education and Experience

  • Bachelor's Degree in Materials Engineering, Industrial Engineering, or a related engineering discipline preferred.

  • 4–5 years of related experience.

  • Medical Device industry experience required.

  • Experience in packaging, labeling, validation, process development, or manufacturing engineering environments.

  • Strong computer proficiency including:

    • Microsoft Office Suite

    • Email

    • Database management

    • Spreadsheets

    • Technical reporting

  • Strong verbal and written English communication skills.

Other Skills and Abilities

Technical Competencies

  • Strong understanding of medical device packaging, labeling, and sterilization processes.

  • Experience executing packaging validation activities and test methods associated with:

    • Pouch sealing

    • Tray sealing

    • Packaging verification

    • First Article Inspection (FAI)

  • Experience with problem-solving methodologies and root cause analysis.

  • Statistical knowledge required.

  • Ability to perform:

    • Normality Testing

    • Process Capability Analysis

    • Design of Experiments (DOE)

Professional Competencies

  • Strong teamwork and collaboration skills.

  • Ability to work with limited supervision.

  • Quick learner with the ability to independently acquire new technical knowledge.

  • Strong time management and organizational skills.

  • Effective written and verbal communication skills.

  • Ability to manage complex projects and competing priorities.

  • Ability to lead technical teams and coordinate activities across multiple functions.

Communication Skills

  • Ability to read, analyze, and interpret customer and supplier requirements.

  • Ability to respond effectively to inquiries from customers, suppliers, regulatory agencies, and internal stakeholders.

  • Ability to write:

    • Technical reports

    • Engineering memorandums

    • Feasibility assessments

    • Project assessments

    • Validation documentation

  • Ability to present technical information to:

    • Management

    • Directors

    • Customers

    • Suppliers

Problem Solving

  • Ability to solve practical problems involving multiple variables and limited standardization.

  • Ability to interpret complex requirements and priorities to develop effective implementation strategies.

Travel

Moderate travel required.

Comments

This job description outlines the primary recurring responsibilities of the position and is not intended to be all-inclusive. The incumbent may be assigned additional duties, special projects, and other responsibilities as required to support business objectives.

Skills

Compliance