Senior Project Engineer – Dublin

This is an excellent opportunity to join a leading medical device multinational. If you are experienced in leading the design and development of medical device products through to full life cycle.

Responsibilities:

  • Ensure relevant and innovative product development solutions.
  • Responsible for successful and timely completion of designated tasks.
  • Application of Design for Manufacturing/Assembly (DFM).
  • Define tolerance stack-up analysis for complex mechanical assemblies.
  • Investigate mechanical errors in device performance.
  • Provide guidance for FEA analysis.
  • Lead development of appropriate test plans to fully characterize devices under development.
  • Conduct design reviews, FMEA’s and design verification programs.
  • Prepare technical documentation.
  • Manage and assess external vendors/supplier work and capabilities
  • Support design validation and process validation programs.
  • Maintain DHF with mechanical design deliverables and lead device design transfer and manage post approval device changes.
  • Define control strategy for the finished product.
  • Support regulatory submissions and approvals.
  • Support post approval regulatory submission.
  • Lead technical aspects for managing marketed product changes.
  • Collaborate with multidisciplinary team to develop pipeline products and to support launch market support globally.

Requirements:

  • BSc. in Mechanical Engineering, Biomedical Engineering, Engineering Technology or relevant.
  • 8+ years’ experience in the development and registration of medical devices.
  • Experience of working with GMP, international device regulations and design controls.
  • Understanding of product development considerations for tightly controlled, high-volume manufacturing processes.
  • Experienced driving the design of plastic components.
  • Excellent problem solving methodology, using industry accepted concepts and tools.
    Ability to develop relationships and collaborate across the team.
  • Some international travel required.
  • Must be authorised to work in Ireland.

Advantageous:

  • Knowledge Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
  • Strong materials background.
  • Extensive experience with Solidworks or other CAD software.
  • Experience in project management.

 

Please contact Mary-Ann Keena to learn more

maryann@emechrecruitment.ie

+353 (0) 83 0220666

Refer a Friend