This role is positioned within the engineering team based in Galway. The site provides testing and other technical services to the medical device and pharma industries.

The role requires the use of project management skills, high technical aptitude and extensive on-job experience. They routinely interface with customers therefore a high commercial awareness and interpersonal skill is essential.

Authorised to perform specific activities including:

a) develop, modify, verify and validate methods

b) analysis of results, statements of conformity and opinions / interpretations

c) report, review and authorize results

Duties

• Manages multiple complex customer testing projects simultaneously
• Leads device and packaging testing projects for medical device and pharma customers
• Interfaces with Customers and sales team to assess feasibility and costings of new projects
• Develops and agrees project plans, test protocols and test methods with Customers
• Coordinates staff and schedules equipment resources to execute testing and reporting of results
• Designs and documents test jigs and fixtures
• Working with the validation team to conduct Test Method Validation studies
• Assess equipment specifications and suitability for test method
• Develops URS for laboratory equipment procurement
• Support Quality team with investigations, procedure updates and audits
• Engage in lean and continuous improvements onsite

Education

• Bachelor's Degree

Required Experience

• Medical device verification and validation / regulatory submission project experience
• Customer facing experience
• Device verification and validation / regulatory submission project experience
• Proven project management track record
• CAD and Minitab software experience an advantage

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

For further information on this please contact Johanne Kennedy on 0864403725 / choices@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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 your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.