System Designer

Philips

12 - 17 years

25 - 30 Lacs

pune

Posted:-1 days ago| Platform:

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Skills Required

mechatronics medical devices data analysis iso 13485 analog hardware design healthcare product design black belt auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Your Role:

Ensure Mechanical design alignment with system-level architecture, requirements, and technical strategy.
Incorporate safety, reliability, quality considerations into design from concept phase onward & define test strategies, verification plans, and compliance methods aligned with international standards and Norm Compliance teams.
Lead feasibility assessments and concept evaluations to validate technical options and risks.
Ensure design meets performance, regulatory, compliance, and cost targets.
Perform or review quality, safety, and certification testing, ensuring audit-ready documentation.
Creating and/or participating in design reviews and risk assessments (e.g. FMEA, DFM, Field data analysis, verification reporting)
Lead structured RCA for field issues, integration challenges, CAPA and design failures, ensuring permanent corrective action.
Mentor and coach engineers (electrical, mechanical) to strengthen technical capability and design maturity.
Stay current with emerging technologies, standards, and industry trends relevant to the domain.
Work closely with internal and external stakeholders to ensure smooth collaboration and alignment with product goals.
Alignment with other functions (norm compliance, test and validation, purchase, quality, other).
Conducting early integration tests on predefined prototypes and addressing supplier issues will also be your responsibility. You will follow up on any necessary actions.
Execute verification of units and parts according to your assignment.
Demonstrated contribution across all phases of the product development lifecycle (V-Model), including Requirements, Design, Development, Verification, Integration, and Sustenance
Prior involvement as a lead member in a New Product Innovation (NPI) team or LCM, driving the development of at least one product from concept to launch.

You are a part of Infrastructure department in Mechatronic Development Cluster within the IGT Fixed Systems R&D organization. The department consists of an open and multi-cultural team working towards new product introductions (NPI) of image guided therapy system.

You are fit if:

Bachelor s or master s degree in mechanical engineering or equivalent
Minimum of 12+ years of relevant R&D working experience in medical domain.
Experience in product design, development, maintenance, validation cycle, regulatory norms of released products. (Preferable experience in IEC60601-1-2 & and ISO 13485).
Excellent design documentation skills.
Result oriented and self-steering with a problem-solving attitude.
Good Knowledge of Embedded Analog and Digital hardware design, experience in new product introduction or life-cycle development in a regulated industry
Ability to work independently & to act proactively.
Open-minded, eager to improve for better efficiency with Excellent communication skills and Positive can do attitude.
Work experience in Agile Release Trains following SAFe framework will be preferred.
Quality mindset, A Six Sigma Green Belt/ black belt will be a plus.
Experience in utilizing AI platforms and working with AI-driven tools would be a plus.
Experience in user interface (UI) design will be an added advantage.
Knowledge of FDA guidelines and compliance requirements for medical devices will be preferred.
Ability to present and articulate ideas to key stakeholders and leadership team.

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