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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:
1. Develop, modify, verify and validate methods
2. Analysis of results, statements of conformity and opinions / interpretations
3. Report, review and authorise results
Duties
1. Manages multiple complex customer testing projects simultaneously
2. Leads device and packaging testing projects for medical device and pharma customers
3. Interfaces with Customers and sales team to assess feasibility and costings of new projects
4. Develops and agrees project plans, test protocols and test methods with Customers
5. Coordinates staff and schedules equipment resources to execute testing and reporting of results
6. Designs and documents test jigs and fixtures
7. Working with the validation team to conduct Test Method Validation studies
8. Assess equipment specifications and suitability for test method
9. Develops URS for laboratory equipment procurement
10. Support Quality team with investigations, procedure updates and audits
11. Engage in lean and continuous improvements onsite
Education Degree
* Bachelor's Degree
Required Experience
1. Medical device verification and validation / regulatory submission project experience
2. Device verification and validation / regulatory submission project experience
3. Proven project management track record
4. 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. STERIS strives to be an Equal Opportunity Employer.
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