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Project Engineer

hace 2 semanas


Alajuela, Alajuela, Costa Rica Doris Peters & Asociados A tiempo completo

We are seeking a
Project Engineer
to lead the planning, design, and execution of construction and facility improvement projects within the medical device industry.

This role combines
technical leadership and project management
, ensuring compliance with quality, safety, and regulatory standards such as
GMP, FDA, and ISO 13485
.

Key Responsibilities

  • Lead the planning, design, and execution of construction and renovation projects, including cleanrooms, utilities, production areas, and offices.
  • Manage project schedules, budgets, and resources, ensuring timely delivery of key milestones.
  • Ensure full compliance with
    Good Manufacturing Practices (GMP)
    ,
    FDA
    ,
    ISO 13485
    , and company
    EHS
    standards.
  • Review and validate technical specifications, engineering drawings, and construction packages.
  • Collaborate with contractors, architects, and consultants to align designs with operational and regulatory needs.
  • Support
    commissioning, qualification, and validation
    activities for facility systems and utilities.
  • Lead
    Design for Manufacturability (DFM)
    and product/process transfer to commercial manufacturing.
  • Prepare and present technical reports, project updates, and risk assessments to senior leadership.
  • Provide input on re-engineering opportunities to improve process performance and product quality.
  • Mentor engineers and provide technical guidance to cross-functional teams.
  • Oversee installation and validation of new or existing production lines, ensuring regulatory compliance.

Requirements
Qualifications

  • Bachelor's degree in Engineering or related field.
  • 5+ years of experience
    as a Project or Program Engineer in the
    Medical Devices industry
    .
  • Fluent in
    English and Spanish
    (minimum B2 level).
  • Experience with
    risk management
    ,
    ISO 13485
    , and
    21 CFR Part 820
    and their impact on project schedules and documentation.
  • Proven experience leading validation project plans for medical device products and processes.
  • Strong problem-solving, communication, and conflict management skills.
  • Experience in product and process transfer projects is a plus.
  • PMP certification
    is a plus.
  • MBA
    is a plus.