Sujel Miah
Senior Product Design Support Engineer @Getinge
Signup · Get unlimited contacts
WORK HISTORY
Senior Product Design Support Engineer @Getinge
An innovative medical engineering and service group, providing patient environment solutions within the healthcare market - worldwide.• Control and management of the Engineering Changes to data, products and processes across cross-functional international based teams. Verification and validation of solutions before controlled implementation.• Facilitate and support the business needs for ongoing technical support and upgrade/spares on current and legacy products. Ensures that maintenance, support and spares are managed in advance of their obsolescence. Supports after sales and complaint handling teams in reporting and investigating adverse incidents.• Liaise with product management, visual designers, editors, engineers and clinical advisors to deliver product/project direction and specification. Trained user of Solidworks (Product Design Software) which is used to create parts/products that comply with latest regulatory standards IEC60601-1 and IEC60••••11, from initial concept through to launch.• Managing OEM suppliers and 3rd party manufacturers of ArjoHuntleigh branded medical devices and working closely with the regulatory and compliance department helping with the management of registrations for products into all major markets, including US 510k registration.• Working within, and leading, globally based CAPA teams in managing and resolving internal and external quality issues.• Part of a global project team involving UK, Poland, China and Sweden with the task of bringing our extensive products to the latest 3rd Edition and Homecare regulatory standards. This involved learning understanding the specific changes in compliance and then working with our notified body (BSI) and UL (Test House) to manage and update the required changes to DHF and Technical Files for FDA and CE compliance.• Supporting regulatory audits. Key member of a successful FDA audit team in November 2011.
EDUCATION
Denbigh High School
GCSE's
Dunstable College
Diploma, OND and HNC Mechatronics, Engineering
University of Bedforshire
Bachelor's degree, Integrated Engineering, Upper second 2:1
SKILLS
ABOUT SUJEL MIAH
A proficient Technical Engineer with the ability to blend product design and engineering…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.