Return to jobs

NPI Validation Engineer

Role Type
Gavin Moran
+353 87 410 8620
click here
See Similar

NPI Validation Engineer

As a member of the New Product Introduction Team, the NPI Validation Engineer plays a crucial role in ensuring the effective management of product introductions and change controls, aligning with the requirements of ISO 13485, MDD 93/42/EEC, and MDR 2017/745.


The NPI Validation Engineer's responsibilities include, but are not limited to:

  • Ensuring that new product introductions and change controls comply with ISO 13485, MDD 93/42/EEC, and MDR 2017/745 regulations.
  • Participating in new product introduction programs and ensuring their adherence to ISO 13485 standards. When necessary, generating Product Technical Files and associated studies as required by MDD 93/42/EEC and MDR 2017/745.
  • Completing the Validation Programme, which involves performing Risk Analysis, creating a Validation Master Plan (VMP), conducting Qualification (IQ/OQ/PQ) as per procedure QAP and other related procedures.
  • Preparing technical reports to support completed Validation Programmes.
  • Reviewing and releasing batch paperwork to facilitate product release.
  • Applying Quality Engineering tools like FMEA, FTA, Root Cause Analysis, and DOE in the development of new products or processes related to raw materials, services, and finished products.
  • Providing support for NPI Quality, including handling deviations, non-conformances, performing root cause investigations, and contributing to CAPA writing and reviews.
  • Adhering to plant safety and health & safety requirements, taking responsibility for ensuring the health and safety of oneself and others.
  • Being aware of the potential environmental impacts associated with work and reporting non-conformance incidents.
  • Contributing to energy conservation efforts (e.g., lighting, equipment, air conditioning) to enhance energy performance.
  • Participating in continual improvement activities for OH&S, Environmental, and Energy Management systems by providing feedback/suggestions and reporting incidents promptly.

Skills and Experience:

  • Excellent communication skills, capable of effectively engaging with individuals at all organizational levels.
  • Ability to work collaboratively across different functions within the organization.
  • Demonstrates high performance behavior and fosters a culture of engagement within the NPI Team.
  • Proficient in project management of NPI & PD projects, utilizing appropriate methods and tools such as PMBOK and Agile PM Methods.
  • Experienced in leading problem-solving and process improvement projects of medium to high complexity using Six Sigma methodologies.
  • Proven expertise in Product and Process Validation.


  • Experience in Grinding, Moulding, EDM, and/or Laser processes would be an advantage.
  • Degree in Engineering/Manufacturing/Quality with emphasis on Devices/Biomedical.
  • Ideally, 4-5 years of prior experience as a Quality/Validation Engineer in the Medical Device/Pharma Environment.

For further information on this role please contact Gavin Moran on 087 410 8620 or 

Check out all our open jobs on our HERO Recruitment website

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

See Similar

Search Jobs

Match my CV

We take the hard work out of finding you a new job. Simply upload your CV (or call us) and we’ll get hunting for you!