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Extrusion Engineer

Biomerics · Cartago

Nouveau
🇬🇧 English
validation documentation ISO 13485 medical device manufacturing DOE ANOVA frequency distribution test reliability correlation sampling theory factor analysis

Description du poste

About the role

We are seeking a highly organized Extrusion Engineer to lead the transfer and optimization of high‑volume extrusion processes. You will act as the engineering liaison with vendors, suppliers, and customers, ensuring smooth project execution and compliance with specifications.

Key responsibilities

  • Provide regular reports and updates on strategy, adjustments, and progress to project stakeholders.
  • Represent engineering in high‑volume extrusion operations, maintaining clear communication with all parties.
  • Design, validate, and implement extrusion processes to meet customer specifications and satisfaction.
  • Drive continuous improvement by supporting operational performance indicators.
  • Identify, qualify, and approve extrusion‑related projects.
  • Draft, execute, and report validation documentation (procedures, routers, specifications, Q/OQ/PQ protocols).
  • Guide technical personnel during validation runs and engineering trials.
  • Adjust and program extrusion equipment in collaboration with operators.
  • Validate and qualify equipment, transferring data into DCRs, specifications, MPs, drawings, and tooling.
  • Identify productivity opportunities and propose engineering or capability studies.
  • Train personnel on safety standards, operating procedures, and workflow.
  • Prepare budgets and support quotation processes with technical cost analysis.

Required profile

  • Bachelor’s degree in Materials, Chemical, Industrial, Electromechanical Engineering or related field.
  • Minimum 5 years of experience in plastic manufacturing environments.
  • Experience in regulated industries, preferably medical device manufacturing under ISO 13485.
  • Proven experience supervising personnel.
  • Intermediate to advanced English proficiency (B2–C1).

Required skills

  • Extrusion process design and equipment programming.
  • Validation documentation (Q/OQ/PQ) and equipment qualification.
  • ISO 13485 compliance and medical device manufacturing knowledge.
  • Statistical tools: DOE, ANOVA, frequency distribution, test reliability, correlation, sampling theory, factor analysis.
  • Technical documentation management (DCRs, MPs, drawings, tooling).
  • Continuous improvement and productivity analysis.

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Biomerics

Cartago