Systems Engineer - Medical Device & MedTech Systems

Philips; Pune District; On-site; INR 1,500,000 - 2,600,000; Full time

Job summary

Philips Pune location seeks a Systems Engineer with 8–12 years in analog/digital engineering and strong systems engineering background in MedTech. You will drive DFMEA, risk management, regulatory alignment and integration across platform and third-party devices to deliver robust patient solutions.

You will collaborate with R&D centers in India and global teams to apply AI, Six Sigma, and design for manufacturability, while maintaining high quality, cost, and schedule performance across the

Qualifications

• 8 to 12 years of analog & digital engineering experience
• Hands-on with design controls, DFMEA, risk management
• Experience in medical device regulatory standards

Responsibilities

• Define and mature system requirements and interfaces
• Perform DFMEA, risk assessment and safety analyses
• Lead cross-functional execution to ensure architecture compliance
• Develop test scopes and verify/validate plans and reports

Skills

Analog & Digital

Systems Engineering

DFMEA

Regulatory Compliance

Stakeholder Management

NPI & PLM

Education

Bachelor's in Mechanical/Electrical/Mechatronics/Biomedical Eng

Masters preferred

Tools

TrackWise

Windchill

DOORs

ClearQuest

Job description

Systems engineer

Job Title Systems engineer Job Description #EOS #PHILIN Job Title Systems Engineer Role: Create, develop projects and lead high impact projects backed by strong business cases in complex Image guided therapy systems As part of Systems Engineering team: Drive continuous improvements across legacy and platform systems to support global product health & performance. Apply AI, Six Sigma methodologies & continuously improve efficiencies, cost down for improved order intake & margin expansion with cross‑functional collaboration. Perform DFMEA, risk management, Perform safety assessment of medical device in a cross-functional environment Develop system level compatibility reports between Philips platform to third party medical devices that form a solution to the customers (patients & hospitals) Interact with cross functional stake holders to assimilate relevant information to mature the scope of various sustenance problems, 3rd party compatibilities/ideas in the IGT‑S business Left-right look of & analysis of problem/idea under consideration to evaluate the inter-disciplinary engineering impacts and opportunities (interface design specifications, interface usage specifications, signal integrity, speed & power efficiency, system integration, functional system engineering, technology upgrade, EMC, reliability, manufacturability, usability) Fine tune the requirements, design, verification and integration of module/sub-system in accordance with the higher-level architectural requirements and design specifications Ensuring that the design is consistent with the higher-level architecture and requirements Responsible for ensuring that the design meets the performance, quality and cost criteria Conduct concept and feasibility studies, address Corrective and Preventive Actions, complete the technical maturity analysis (including design specification availability, assessment of the extent of design efforts required) of the problems / ideas under consideration. Define the test scopes Ensuring the release of Design Verification & Validation plan & reports Norm (Standards) and Regulatory Compliance Impact Analysis Product Safety Risk impact analysis for the problem/idea under consideration Report out the technical maturity, risk and mitigation strategies to the relevant stakeholders and facilitate the go/no-go decision about the problem/idea Partner with project manager to define engineering scope and work breakdown structure Ensuring that there is proper documentation per relevant standards & Quality Management System for the developed/assessed design Ensuring the mutual consistency and efficient integration of the separate components in modular design that meets the product specification Drawing up personal schedule and reports on progress Being abreast of technical developments in own field through study of literature and technical contacts Maintaining product and company reputation by complying with country specific regulations Problem/idea evaluation and efficient verbal/written communication Handles the integration and optimization of a single component or straightforward subsystem within the system, ensuring seamless transfer and adherence to established quality and performance standards.

Global Collaboration Work closely with Philips R&D centers across India (Pune, Bangalore) and global teams in the Netherlands and across the worldwide supply base, operations, Service and markets. Integrate diverse industry technologies, trends (example AI, predictive condition monitoring of installed base) into Philips products, solutions delivered to hospital customers.

Minimum required Education

Bachelors in engineering in Mechanical / Electrical / Mechatronics/ Bio-medical engineering and with a flair for systems engineering in MedTech devices. Masters degree is a preference

You’re the right fit if

• 8 to 12 years of Analog & Digital engineering experience with solid system engineering understanding
• Hands-on experience with tools like Track Wise, Clear-quest, Windchill, DOORs or equivalent will be an added advantage
• Disciplined & result oriented team player
• Ability to work independently under minimal supervision
• Ability to present and articulate ideas to key stakeholders and leadership team
• Excellent communication skills and a Positive ‘can do’ attitude
• Quality mindset in design and documentation
• Global and Cross-functional Experience/Skills in a Matrix Organization will be an added advantage
• New Product Introduction (NPI) and Product Life Cycle Management Product Obsolescence Management/Sustenance and Value Engineering Understanding & on the job application of standards like ISO 14971, ISO 13485, IEC 60601-1
• Understanding & exposure to regulatory aspects pertaining to FDA, MDR, NMPA, TGA, HC, MHLW
• Understanding & Exposure to D/P-FMEA, Design for Usability, Design for Manufacturing/Assembly, Design for Reliability
• Understanding of Supplier Quality Management, Manufacturing Engineering, Operations and procurement will be added advantage
• Strong experience in systems engineering within complex mechatronic, imaging, or MedTech systems.
• Demonstrated ability to operate in multi-disciplinary technical teams and influence global stakeholders.
• Experience in requirements engineering, requirements flow-down to component level, performing DFMEA, product concept development, Element requirements development, Experience V&V, system integration, and risk management in hardware products
• Proven background in sustaining engineering, supply chain improvement, or lifecycle management and driving cost down.

Preferred Experience

Medical Device Industry Experience

Preferred Skills

Systems Engineering Hardware Engineering Regulatory Compliance Stakeholder Management Project Management Technology Acumen System Testing Testing Procedures & tools Process Improvements Supplier Transfer Expertise Supplier Quality Management

Primary Location

Pune

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

Experience Level

Senior Level