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Manufacturing Engineer

hace 3 semanas

Tijuana, Baja California, México ITRS Recruiting Services A tiempo completo

Purpose of the position

An international company in the medical sector is looking for a
Manufacturing Engineer
with proven experience in
precision mechanical assemblies
,
3D printing
, and
participation in production line transfers
.

This role is key in the implementation and validation of new processes, ensuring efficiency, regulatory compliance, and world-class quality.

Main Responsibilities:

  • Execute
    manufacturing process transfer and validation
    activities, ensuring compliance with quality standards and regulatory requirements.
  • Develop and optimize
    precision mechanical assembly
    and
    3D printing
    processes, ensuring dimensional accuracy and functional performance.
  • Prepare and maintain
    BOMs, process routes, work instructions, and technical documentation
    according to GMP guidelines.
  • Implement
    continuous improvement tools (Lean, Six Sigma)
    to increase productivity and reduce waste.
  • Support the
    design and validation of tooling, fixtures, and production layouts
    .
  • Conduct
    IQ/OQ/PQ validations
    ,
    capability studies (Cp, Cpk)
    , and
    root cause analysis
    .
  • Train operational staff in new processes and
    safe manufacturing practices
    .
  • Ensure compliance with
    safety, quality, and environmental
    standards in operations.
  • Coordinate with
    local and international multidisciplinary teams
    to ensure successful transition of transferred processes.

Requirements:

  • Bachelor's degree in
    Industrial, Mechanical, Biomedical, or Materials Engineering
    (required).
  • Minimum 3 years
    of experience in manufacturing within
    regulated industries
    (preferably
    medical devices
    ).
  • Proven experience in
    precision mechanical assemblies
    and
    3D printing processes
    .
  • Knowledge of
    process validations (IQ/OQ/PQ)
    and
    continuous improvement methodologies
    .
  • Proficiency in
    statistical tools
    (SPC, Minitab, GR&R).
  • Intermediate to advanced English
    ; able to interact with global teams.
  • Valid visa and passport.

Preferred Qualifications:

  • Experience with
    international process transfers
    .
  • Green Belt certification
    or
    Lean Six Sigma training
    .
  • Knowledge of
    ISO 13485 and FDA regulations
    .
  • Experience using
    SolidWorks design software
    .

Key Competencies:

  • Analytical thinking & problem-solving
  • Planning and organization
  • Results orientation
  • Effective communication
  • Collaborative and intercultural teamwork
  • Focus on quality and continuous improvement

What's Offered:

  • Participation in an international
    technology transfer project
    .
  • Professional growth in a
    global, innovation-driven company
    .
  • Benefits above regular requirements.