JOB DESCRIPTION
A Day in the Life
As an Standards Engineer you will learn and collaborate with the sustenance and engineering team. You will be connected with Product Development, Medical Devices Design Controls, and Medical Device Regulation activities.
- Engineer is responsible for supporting the Design Controls, Medical Device Regulations Gap Assessment and Remediation activities.
- Engineer is expected to have the appropriate Knowledge / Experience on product development and cross-functional aspects.
- It is expected that the Engineer is capable of learning the product and process quickly.
- Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Must-Have :
Bachelor's Degree in Mechanical Engineering / Bio-Medical / Bio-Tech with 3 to 5 Years of professional experience.Good knowledge on medical device regulations like IEC-60086, ISO-22442, FDA Guidance etc.Theoretical Knowledge on Medical Devices.Knowledge of Creo or any modeling Software and Manufacturing Operations.
Excellent Communication - Written and Oral.
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Skills Required
Creo, Manufacturing Operations