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

Responsible for the correct process and transfer of capital equipment from the design stage into full production for NPD projects. Facilitate sustaining engineering projects by design changes and improvements of current production models for efficiency and quality gains, managing all stages from conception through to implementation. Ensure continued output of finished goods by establishing new and alternative component options from current or secondary vendors without deviation to the BOM, function and spec of finished goods, as per the design technical files. Working with Production, R&D and Quality departments, the position is responsible for all alterations to the capital portfolio following assessments for suitability, test, validation, and all aspects of implementation, while maintaining compliance to the Medical Device Directives.

Duties

-    Responsible for the adequate Design Transfer into Production, including accurate drawings, schematics and BOM
-    Ensure the design implementation is clearly and accurately translated into production build instructions
-    Lead planning and organisation of design transfer events (Production Preparation) executed by the mechanical/electrical/electronics/software design team
-    Meet internal quality procedures and external standards
-    Implement, as needed, new methods
-    Assist in modifications to equipment to achieve the desired improvements
-    Support production and/or suppliers
-    Ensure product and process validation (pFMEA)
-    Support the Continuous Improvement (CI) manager in optimising production processes
-    Troubleshoot and resolve process issues
-    Liaise with Development to resolve design issues in production
-    Resolve CAPA and complaint investigations with the Quality Department
-    Work with design and purchasing teams to mitigate supply chain issues with suitable alternative components according to tech files and regulatory certification listings
-    Create, implement and modify electronic build manuals and work instruction documents for factory operators
-    Manage BOM, technical drawings and work instructions following change or up issue for continued accuracy and identify training requirements
 

What skills/experience we are looking for in our candidates

-    MSc Degree in engineering or technical field; or equivalent training and experience
-    At least 2 years of experience in design transfer to production
-    Strong project management skills required
-    Be diplomatic and tactful
-    Possess a practical style and positive attitude
-    Ability to effectively handle conflict through proactive action, and direct and timely communication.
-    Ability to resolve product quality issues through interdepartmental teamwork
-    Ability to make sound data driven decisions; understand, track, drill down and question activities and issues in all functional areas.
-    Has LEAN exposure (2P, Kaizen, DFMAS)
-    Maintain a high attention to detail and provide well thought-out solutions
-    CAD experience is advantageous.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.