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Principal Engineer, Systems

Principal Engineer, Systems

Vantive

7 - 11 years

13 - 17 Lacs

bengaluru

Posted:5 days ago| Platform:

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Skills Required

medical devices finance system integration resourcing product design new product development system development risk management biomedical recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

A Systems engineering professional with experience in Systems areas like Product Requirements

management, Traceability, DHF structure maintenance, Product Risk management, System integration and Verification Validation of medical devices. This position may own perform relevant Systems activities for a family of dialysis devices as they are used in dialysis therapy.

Essential Duties and Responsibilities:

Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation. Come up with the recommended mitigation with the rationale.
Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities.
Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering.
Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability.
Working knowledge of FMEAs and standards applicable to Systems Engineering.
Creates design concepts and research methodologies that best meet current and future customer business needs for a product or process domain area.
Understands clinical and user needs and is able to apply to product realization. Creates and maintains Design History File elements.
Successfully influences stakeholders and cross-functional team members within the project.
Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.

Qualifications:

Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems with software .
A demonstrated track record in electromechanical system development, preferably medical devices and medical grade water devices .
Proven ability to create results within budget, timeline, and product/project deliverable.

Education and/or Experience:

An engineering graduate in Electronics, Electrical, Biomedical or related engineering discipline and 10+ years of relevant experience. Prior experience in Medical/Renal device domain is a plus.

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Principal Engineer, Systems