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Senior Manufacturing Engineer in the Medical Devices industry

Job Overview

We are hiring a Senior Manufacturing Engineer in the Medical Devices industry

We are looking for a highly skilled professional to drive the development, implementation, and continuous improvement of manufacturing processes. This role plays a critical part in ensuring compliance with product specifications, quality standards, and FDA regulations.

Key Responsibilities

  • Perform installation and validation activities for production lines, including equipment, process, product, and test method validations, in compliance with regulations.
  • Design and implement manufacturing processes, procedures, and production layouts for assemblies, equipment, and material handling.
  • Support product improvements in areas such as risk management, test method validation, process validation, process control, supplier qualification, complaint investigations, CAPA, and process improvement.
  • Execute and manage documentation in PLM systems (e.g., update DHRs, BOMs, work instructions, and create part numbers).
  • Investigate and resolve production issues using structured problem-solving methods.
  • Lead or support cross-functional manufacturing projects and initiatives.
  • Provide guidance to engineering teams on design concepts and specifications to optimize manufacturing efficiency.
  • Ensure compliance of processes and procedures with all applicable regulatory requirements.

We are seeking a results-driven engineer with a strong technical background and proven ability to lead complex manufacturing initiatives. If this opportunity aligns with your expertise, we encourage you to apply.

Requirements

Qualifications

  • 5+ years of experience as a Manufacturing Engineer in the Medical Devices industry.
  • Fluency in English and Spanish (minimum B2).
  • Experience leading validation plans for medical products and processes.
  • Hands-on experience in product and process transfers.
  • Strong background in root cause analysis and problem-solving methodologies.
  • Project Management experience is considered a plus.
  • Strong documentation and communication skills.

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