Development Engineer

6 months ago


Galway, Ireland STERIS Full time

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

This role is positioned within the engineering team based at the STERIS Galway laboratory. 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 authorise 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

Duties - cont'd

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 Degree

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

Preferred Experience

Skills

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.



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