Principal Eng, Systems

Vantive Healthcare Technologies; Bengaluru; On-site; INR 1,200,000 - 2,500,000; Full time

Job summary

Vantive Healthcare Technologies seeks a Systems engineering professional with extensive experience in product requirements management, traceability, DHF structure maintenance, and system verification and validation for medical devices used in Acute Therapies.

You will own and perform key systems activities across a family of devices, collaborate with cross-functional teams, ensure compliance with FDA, ISO and IEC design controls, and drive change control and risk management through the product

Qualifications

• Gathers inputs for requirements from standards, user needs, regulatory, quality and manufacturing.
• Implements impact assessments for proposed design changes and mitigations.
• Demonstrates knowledge of safety and regulatory design controls.
• Tracks and maintains DHF elements and system verification activities.

Responsibilities

• Performs systems engineering across product lifecycle from development to post market.
• Owns requirements traceability and cross-functional integration.
• Leads change control ownership and timely closure.
• Prepares reports and presents to RD leadership weekly.
• Drives risk management and reliability discussions across teams.

Skills

Systems engineering

Electro-mechanical systems

Medical devices

Regulatory standards

Education

Engineering degree (Electrical/Mechanical/Biomedical)

Tools

FMEAs

Design History File

Change Control Management

Job description

Job Summary

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 devices as they are used in Acute Therapies.

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 resource 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.
• Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization in Acute Therapies.
• Owner of RD program schedule creation, tracking, and execution. Responsible for delivering an integrated product with detailed plans from primary iteration to successful system verification completion.
• Participates as a member of cross functional teams and/or integrates cross functional inputs into project delivery.
• Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Drives Change Control Management records as Change owner and ensure timely closure.
• Prepares project reports, analyses and delivers presentations to RD leadership on a weekly basis.
• Leads scheduled meetings in RD, develops and manages agenda, creates minutes, and follows up action items throughout the integration steps.
• 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.

Education and/or Experience

• An engineering graduate in Electrical, Mechanical, Biomedical or related engineering discipline with 8-12 years of experience. Prior experience in Medical/ Acute device domain is a plus.
• Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems.
• A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware