Design Assurance Engineer Job At Pune Full Time

Job Title

Design Assurance Engineer

Job Description

In this role, you have the opportunity to design, develop and maintain Diagnostic X-ray (Radiography, Fluoro & Mammography) and realization of a range of products in such a way that future products options and features can be realized with acceptable effects for the earlier products. You are responsible for identifying appropriate technologies, decomposing the system into subsystems and represent system engineering in development within projects.

You are responsible for

• Carrying out all Design Assurance activities of assigned product(s)/product line(s) as per the global system engineering process
• Ensure technical content of each releases are in adherence to design principles, which includes but not limited to:
  • Assure the quality of design implementations on system, subsystem and component level across the DXR portfolio.
  • Support several areas of system engineering techniques in system and subsystem programs across all DXR sites to achieve high quality and reliability. Examples for these techniques are , Requirement and functional decomposition and tracing ,Design Margin Analysis ,FEA, circuit simulation, timing simulation, DfSS, HALT, HAST.
  • Support Defining and consistent improvement of quality and reliability engineering procedures for DXR.
  • Support in creating, maintaining, and governing the usage of general design guides for DXR X-ray systems.
  • Support the Design Assurance Leader / System Designer / Architects of the system / Sub-system programs in the conduct of design reviews.
  • Ensure as Independent reviewer that development activities are in adherence to acceptable design principles.
• Ensure each releases are in compliance to Design Control process and principles, which includes but not limited to:
  • Assure adherence to design control process for design activities. This include adherence to ISO13485 as well as 21CFR820 design control principles.
  • Establish processes to ensure findings, risks, recommendations and outcomes are clearly documented and communicated.
  • Ensure proper requirements capturing, progression towards design, verification, validation and tractability during development cycle and life cycle management.
  • Facilitate the identification and deployment of resources to investigate and resolve issues in a timely and effective manner.
  • Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
  • Establish effective review techniques, ensure audit compliance.
  • Provide oversight and monitoring of all phases of design to ensure compliance and timely resolution. Support and lead FMEA/Risk Management processes and activities.
  • Work with business process owners to devise appropriate metrics to improve product and process.
  • Establish Quality Assurance process metrics. Trend, analyze, and report on quality data; develop recommendations based on data analysis.
  • Support best practices for problem solving, root cause analysis, and solution selection tools
• Is responsible for the achievement of the technical goal/commitment of a project
• Analyze project ideas regarding realization options; evaluate impact on running projects
• Detects common architectural and functional components in order to enable reuse and maintainability
• Cooperate and guide business partners/ suppliers on national/international level
• Be interface to and take complete ownership in managing the hardware/software deliverable from internal and external supplier
• Guide subsystem development teams on system interfacing topics
• Managing that the requirements and design is understood and implemented correctly by the project team
• Reliability and Serviceability of the system / subsystem / components
• Transfer design output to manufacturing line
• Advising on realization, planning and budgets
• Contributing to Technology Roadmaps

You are a part of Diagnostic X-Ray R&D team based out of Philips Healthcare Innovation Center (HIC), Pune. Philips HIC Pune is a product innovation center for multiple businesses with presence of R&D, Marketing, Customer Service, Procurement, Quality and Manufacturing functions. The center is focused on developing smart and reliable X-ray imaging based Diagnostics and Treatment products with enhanced patient safety to meet the unmet needs of a wide range of global hospital customer base.

To succeed in this role, you should have the following skills and experience:

• Completed engineering studies at university level; BE/BTech/ME/Mtech/MS/MSc in Electronics/Electrical/Computer Science
• Total 10+ years’ experience with Minimum 5 years of experience in the X-ray system/subsystem design & development (or at least two end to end X-ray product development)
• In-depth knowledge in selection of System Engineering, Design Assurance at System/subsystem for X-ray based systems
• Knowledge of IEC 60601 standards, risk management, verification and validation of medical devices
• Knowhow of design control processes for medical device design
• System thinking mindset and domain expertise in the related area
• Working knowledge of cabling design, design for EMI/EMC , Design for reliability
• Fast learner and interest to learn new technologies/business/systems
• Ability to present ideas and to convince project team members
• Be structured and self-organized
• Excellent communication skills
• Team player, leadership skills and drive for results
• Mindset to simplify and reach to solutions with speed
• Intercultural sensitivity
• Self-motivation & ability to lead R&D team

In return, we offer you

A chance to serve a bigger purpose. At Philips, our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients drive us. We enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs. Our business provides unique opportunities to develop innovative enterprise software solutions and deliver meaningful solutions in the healthcare space and this new position is a unique opportunity to shape the next generation solutions we are developing.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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