Senior Automation Engineer | New Product Introduction (NPI) | Medical Devices (Ireland)

Optimized Job Description

Calling all passionate and innovative Automation Engineers!

HERO Recruitment is seeking a highly skilled Senior Automation Engineer to join our client, a leading medical device company in Ireland. As a key member of the New Product Introduction (NPI) team, you will play a pivotal role in bringing groundbreaking medical devices, especially catheters, from concept to commercialization.

About the Role:

  • Lead and manage NPI projects, ensuring on-time delivery, high-quality products, and adherence to budget constraints.
  • Oversee all aspects of NPI, including product design, specifications, process validation, training needs identification, equipment layout, production procedures, and material procurement.
  • Integrate the requirements of ISO 13485 (Quality Management Systems), ISO 45001 (Occupational Health & Safety), ISO 14001 (Environmental Management), and ISO 50001 (Energy Management) into design, development, and production processes.
  • Implement and source cutting-edge tooling, equipment, and automation technologies to optimize the manufacturing of new and existing products.
  • Coordinate the supply of extrusions, ensuring agreed-upon specifications for tubing, resins, and quality requirements.
  • Maintain clear and consistent communication with clients throughout the entire project lifecycle.
  • Plan and manage new product design activities, encompassing design inputs, outputs, verification, and validation activities. This may include involvement in clinical trials, technical files, reports, and design history files, adhering to relevant procedures and regulatory standards.
  • Collaborate with the NPI team to develop efficient and cost-effective manufacturing processes, potentially including training production personnel.
  • Design and implement efficient manufacturing cell layouts, workstations, and material handling systems to achieve optimal production targets for cost, quality, and efficiency.

Qualifications:

  • Bachelor's degree in a relevant engineering discipline (Mechanical, Manufacturing, Automation, or equivalent).
  • Master's degree in a related field is a plus.
  • Minimum of 2-3 years of experience in NPI, manufacturing, quality, or process engineering, preferably within the medical device industry, particularly catheter manufacturing.
  • Proven experience in project management for NPI projects, ideally in a medical device environment.
  • In-depth understanding of automation technologies and their application in medical device manufacturing (extrusion, molding, balloon forming, braiding, packaging, assembly).
  • Strong working knowledge of ISO standards for quality management, occupational health & safety, environmental management, and energy management.
  • Excellent communication, collaboration, and interpersonal skills.
  • Leadership qualities and the ability to manage and mentor team members.

Benefits:

  • Competitive salary and benefits package
  • Opportunity to contribute to the development of life-saving medical technologies
  • Work in a dynamic and innovative environment within the medical device industry
  • Be part of a collaborative and supportive team