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Project Engineer (NPI)

Dabster Systems

Posted on Dec 20, 2020 by Dabster Systems

Cork, Ireland
Immediate Start
Annual Salary

Role: Project Engineer (NPI)

Job Type: Permanent/Contract

Location: Cork, Ireland

JOB Description:

Principal Accountabilities:

  1. Process development including PFMEA
  2. Process Characterisation through engineering studies
  3. Process Qualification/Validation
  4. Planning & execution of key deliverables & action plans with the help of the Project Manager
  5. Regular reporting on the status, performance and risks of your project
  6. Participate in DFM reviews with Design Team to minimize life cycle cost
  7. Minimise Environmental and Health & Safety effects of your work
  8. Adhere to the company's procedures as detailed in the SOP manual
  9. Support Regulatory Affairs with product submissions
  10. All other duties as directed by direct manager

Essential criteria:

  1. Third level degree in Biomedical, Chemical, Manufacturing, Production Engineering, Biochemistry or similar discipline.
  2. 1-3 years' experience in general engineering.
  3. Self-motivated, with a focus on Quality, Delivery, and Cost.
  4. Proven Root Cause analysis and problem-solving techniques (A3, 8D, TRIZ, or equivalent).

Desirable criteria:

  1. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD, and FDA CFR 820) and other pertinent Design Control requirements.
  2. 1-3 years' experience in cleaning & packaging process development with Class II/III medical devices or another regulated environment.
  3. Knowledge of Sterility Assurance in a regulated environment.
  4. Knowledge of anatomy and physiology.

Reference: 1041002300

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