• Green Card

• Corp-Corp

• W2-Contract

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 2nd Nov 2021

+ Develops and manages project objectives, plans, schedules, and budget.

+ Maintains project schedule by monitoring project progress, coordinating activities, resolving issues, and proactively managing risks/ opportunities.
+ Manages cross-functional project team to achieve project objectives.
+ Manages the suppliers, vendors, and subcontractors on each project.
+ Proposes and implements design solutions in order to meet product specifications.
+ Responsible for product specification, verification and validation.
+ Conducts project proposals and feasibility studies.
+ Assists in the development and maintenance of product/ project documentation required by Engineering SOPs and national/international quality standards and regulations.
+ Stays up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
+ Delivers medical device design documentation compliant with FDA design controls and good documentation practices
+ Creates and maintains medical device Design History Files and Device Master Records
+ Identifies potential medical device hazards and maintains Risk Management files
+ Conducts medical device safety testing and maintains product compliance with applicable UL, ISO, and IEC 60601 standards as well as international regulatory requirements
+ Investigates and resolves product related Corrective and Preventative Actions using appropriate problem solving techniques (DMAIC, FMEA, Ishikawa, Fault Tree, etc.)