🌎
This job posting isn't available in all website languages

Design Quality Engineer (12 mth contract)

📁
Engineering
📅
17000084 Requisition #
Thanks for your interest in the Design Quality Engineer (12 mth contract) position. Unfortunately this position has been closed but you can search our 1,336 open jobs by clicking here.

As our Design Quality engineer, your Key Accountabilities will involve:


  • Review new and modified product designs for quality characteristics, including     manufacturability, serviceability, testability, reliability, and product requirements.
  • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations.
  • Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report).
  • Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance.
  • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.

 

Skills & Qualifications:

Minimum requirements:

  • BSc Mechanical engineering or related discipline with 3 years’ experience in a similar role
  • Good verbal and written communication skills including protocol / report development and technical presentations.
  • Experience Risk Management ISO 14971
  • Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
  • Experience of verification/validation test plan development and root cause failure analysis.

Preferred requirements:

  • Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Desirable
  • Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.  Desirable
  • Familiar with statistical software tools (Minitab, Stat Graphics, Statistical), Desirable
  • Stability, Biocompatibility, Sterilization, Ship Testing Knowledge, Desirable

 

Other Skills:

  • Computer literate and experience with PCs, networks, and applications
  • DFSS / Lean Green Belt or Black Belt Desirable 
  • Familiar with DMAIC or DMADV(DFSS) methodologies Desirable
  • Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards. Desirable
  • Travel will be required as part of the job with an estimate of 5-10% travel requirements, this position will be based out of Athlone with potential for world wide interfaces/support required. 

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Athlone, County Westmeath, Ireland

📁 Engineering

Requisition #: 240003Z9

FORTUNE NAMES MEDTRONIC TO 'CHANGE THE WORLD' LIST

FORTUNE puts Medtronic among the top 20 companies worldwide having a positive social impact through core business strategy.

Read The Story

ENGINEERING

Bring your talents to help us build life-changing technology

LEARN MORE

Three Women Working

INCLUSION AND DIVERSITY

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

SEE HOW