Select how often (in days) to receive an alert:
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 DegreeBachelor's DegreeRequired Experience Medical device verification and validation / regulatory submission project experience
Device verification and validation / regulatory submission project experience
Proven project management track record
CAD and Minitab software experience an advantage
Preferred ExperienceSkillsSTERIS 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.
Job Segment: Testing, Medical Device Engineer, Infection Control, Medical Device, Developer, Technology, Engineering, Healthcare
#J-18808-Ljbffr
