System Engineer-Medical Devices

6 days ago


Bengaluru, India Excellence and Eminence LLP Full time
We are looking for a TechnicalLead Systems Engineer to drive the design development andintegration of complex medical devices ensuring regulatorycompliance and leading crossfunctionalteams.

KeySkills
Systemsengineering medical device development system integration riskmanagement ISO 13485 and FDA 21 CFR Part820.

Responsibilities
Lead systems engineering efforts for medical device developmentfrom concept to commercialization.
Develop and manage systemrequirements architecture and design documentation.
Oversee hardware software andassay component integration into cohesive systems.
Conduct design reviews riskassessments and ensure compliance with regulatory standards.
Provide technical leadership andmentorship to juniorengineers.

RequirementsBachelor s/Master s in Systems Engineering Biomedical EngineeringElectrical Engineering or related field.
812 years of experience insystems engineering with 3 years in medical device development.
Strong understanding of designcontrol risk management and regulatory standards.
Proven experience with systemintegration and troubleshooting complex electromechanical systems.
Excellent project managementleadership and communicationskills.

BenefitsAboutthe Customer
You will beworking with a trusted global product engineering and lifecycleservices partner to the world s most recognized companies in theAero Engines Aerospace & Defense HiTech Transportation(Auto and Rail) Power and Industrial Oil & Gas and MedicalDevices industries. With 12K experts and a global presence in 73locations across 15 countries it believes that it is at theforefront of the convergence of mechanical electronics software anddigital engineering innovations to enable solutions for a safercleaner world. A Strong Process based organization Certified forCMMI L5 and multiple other certifications of the process and one ofthe few organizations which are ranked as best place towork.

Systemsengineering, medical device development, system integration, riskmanagement, ISO 13485 and FDA 21 CFR Part 820.

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