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APPLY HERE
Location: Pune
Company: Philips
Systems Engineers deliver high quality (subsystems of) products, by meeting user and business requirements, managing complexity, technical leadership, and stakeholder management.
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Your Role
Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance.
- Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification
- System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability.
- Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews.
- Ensuring full Product Safety Risk Management in a regulation compliant manner.
- Managing technological complexity of products in multi-disciplinary settings. Develops products, independently and according to own judgement, using the latest technologies and resources, often realizing systems based on unverified specifications.
- Makes a substantial contribution to the innovation of product and processes.
- Makes independent choices regarding aspects of the design. Gives reasons for changes in specifications.
- Formulates assignments in dialogue with customer or user.
- Submits ideas for future developments and providing tangible input for Technology roadmaps
- Develops partly and sometimes wholly new product, process or technology.
- Elicits, reviews, and characterizes stakeholder feedback; creates and reviews system-user interaction model with various Systems Engineering related Methods/tools
You’re The Right Fit If
- Bachelors in relevant field including Electrical, Electronics, or other related science.
- A minimum of 5 years of experience successfully developing complex medical device (hardware, software, consumables) products for acute/emergency care/hospital markets is necessary.
- Have Systems Engineering certification
- Hands-on experience in ISO 13485, ISO 14971, ISO 20417, IEC 60601-1 and collateral standards.
- Hands-on experience in requirements management including, developing, deriving, flow down, tracing and prioritizing requirements.
- Hands-on experiences in using Model Based Systems Engineering (MBSE) Tools of Cameo and such similar tools.
- Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic and mechanical performance from subsystem to system level for issue resolutions.
- Analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
- Strong understanding of Controls and Software development process including Model-based Design approach and Test-Driven design methodologies.
- Solid understanding of System Verification and Validation test plan/protocols, executing V&V (Verification and Validation) (Verification and Validation) activities, generating, and analyzing test reports.
- Understanding of global medical device regulatory environments and clearance processes.
- Effective communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team.
- Maintains strict confidentiality of sensitive information.
