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Hologic

Develops medical devices for early detection

Manufacturing Engineer 2

Manufacturing EngineeringConfirmed live in the last 24 hours
ContractAlajuela Province, Alajuela, Costa RicaNo salary listedIn-person

About the Job

Requirements

  • A university bachelor's degree in Mechanical, Electromechanical, Industrial, Materials, Chemical, or Electronic Engineering, or an equivalent field.
  • At least 2 years of professional experience in a technical field and in positions of similar nature.
  • Intermediate-level knowledge of Microsoft Office.
  • English proficiency at or above B2.

Responsibilities

  • Develop, improve, and monitor new and existing manufacturing processes, ensuring compliance with FDA and ISO quality requirements and regulations.
  • Identify opportunities to improve processes and reduce production costs, and propose and implement plans to optimize key performance indicators.
  • For new product introduction and internalization, conduct engineering studies and process characterization to optimize processes and resolve existing and potential manufacturing issues, especially during transfers.
  • Provide timely technical support to resolve production-process issues through the Problem Resolution System, addressing assignable causes and systemic problems.
  • Lead or participate in problem-solving teams, organizing and planning activities and providing technical expertise as a subject matter expert.
  • Lead or participate in CAPA/IACA investigations and associated actions related to manufacturing processes.
  • Monitor product and process metrics, especially costs related to scrap, and implement mitigation, correction, and prevention actions to meet established goals.
  • Conduct engineering studies and process characterization to improve and implement fixtures, equipment, and processes related to raw materials and finished products.
  • Identify systemic ergonomics, safety, quality, production, and cost issues; define action plans and follow up on them.
  • For new product introduction and internalization, ensure performance-based KPIs exist for the product being implemented.
  • Develop risk analyses, protocols, and validation reports for processes and fixtures.
  • Review and update existing quality documentation and create new documents and procedures that integrate new processes into the company quality system.
  • Define and train personnel at the GEMBA on acceptance and rejection criteria related to processes, equipment, and fixtures, ensuring consistent quality results.
  • Design and execute engineering studies to improve fixtures, processes, and situations related to raw materials and finished products.
  • For new product introduction and internalization, document all critical process and product requirements, and ensure changes to critical requirements are documented, approved, and effectively communicated to all stakeholders.
  • Provide technical advice to the calibration department about calibrated equipment to ensure proper equipment operation in manufacturing.
  • Coordinate investigations of equipment found out of tolerance during calibration and define actions to take.
  • Lead drills and generate actions to reduce business-continuity risk and strengthen the Business Continuity Plan process.
  • For new product introduction and internalization, ensure appropriate equipment is selected for manufacturing-process applications and, when applicable, develop and deliver training so relevant personnel are properly trained in the use and handling of new technologies.
  • Participate actively in Operational Excellence activities to foster a culture of continuous improvement.
  • Visit the GEMBA to strengthen continuous improvement in manufacturing processes and appropriate scrap control.
  • Carry out continuous-improvement projects to increase productivity and reduce scrap and rework in materials and processes.
  • Participate actively in interdisciplinary teams and daily meetings to identify and resolve critical process issues.
  • Report and analyze actions in meetings with interdisciplinary teams to support the company's strategic objectives.
  • Follow up on and effectively communicate the status of significant or critical projects and activities.

Desired Qualifications

  • Black Belt certification or qualification.
  • Certified Quality Engineer (CQE) qualification.
  • Knowledge of project administration or management, Operational Excellence, and Manufacturing 4.0.
  • Experience with SolidWorks, Minitab, Microsoft Project, and Visio.

About the Company

Hologic

Develops medical devices for early detection

Hologic develops medical devices and diagnostic products for breast health, skeletal health, diagnostics, GYN surgery, and medical aesthetics. Its tests and imaging devices help hospitals and labs screen, diagnose, and guide treatment, while surgical and aesthetic tools support procedures. Revenue comes from product sales and related services. The company aims to improve health by enabling early detection and effective treatment worldwide.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Santa Clara, CA
Founded
1985

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