Design Quality Engineer

Year    Pune, Maharashtra, India

Job Description

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Job Title

Design Quality Engineer - Products & Systems

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it\xe2\x80\x99s not just what we do, it\xe2\x80\x99s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers\xe2\x80\x99 needs. It\xe2\x80\x99s what inspires us to create meaningful solutions \xe2\x80\x93 the kind that make a real difference \xe2\x80\x93 when it matters most. The world and our customers\xe2\x80\x99 needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That\xe2\x80\x99s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. Job Title Design Quality Engineer \xe2\x80\x93 Products & Systems In this role, you have the opportunity to Contribute to IGT Systems\xe2\x80\x99 drive to deliver with speed, high quality products to our customers and their patient whose lives they will improve. As such, you have a key role to enable IGT System to meet their business goals. You will be able to support activities to maintain our launched designs by contributing to the MLD team(s). Furthermore, in this role you investigate and resolve any order issues that prevent the order from being manufactured and delivered. You are responsible for
  • Ensure that appropriate Change plans are made to control the required product changes.
  • Validates key design inputs like useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.
  • Provides effective oversight the execution of the Change plans and of related design and development activities, including risk management.
  • Leading quality related problem solving.
  • Using post-market, factory quality data for analytics and statistics to report on the product\xe2\x80\x99s performance in the market & driving quality improvements.
  • Ensure the product\xe2\x80\x99s design quality related requirements/criteria are fulfilled.
  • Act as a single point of contact (person assigned to) for MLD/ Life cycle management team(s);
  • Support quality improvement initiatives like Factory yield, DEFOA, C&R, etc as needed.
  • Responsible for performing timely on quality engineering tasks like assess product design, reviewing test & other performance data during change process.
  • Responsible to ensure process compliance throughout the engineering change through regular reviews and audits.
  • Ensure sufficient depth in FMEA by proactively participate in FMEA activities; Aim to prevent known issues becoming a C&R by challenging validity of rejected / postponed product defect
  • Taking ownership to investigate orders that have been identified to have blocking issues (so called \xe2\x80\x98NOKs\xe2\x80\x99)
  • Work with key stakeholders like Regulatory, R&D and Manufacturing to resolve these issues and allow start / continuation of manufacturing activities and deliveries.
  • Flag products/parts that have not yet been fully released or cleared, to prevent unauthorized deliveries.
  • Challenging status quo to improve product quality and compliance as a continual improvement in respective area.
You are a part of You will be part of the global Philips Q&R organization and will be reporting within the Design Quality team for IGT-Systems. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations. To succeed in this role, you should have the following skills and experience. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life, not just as a job. We\xe2\x80\x99re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year. Specific skill requirements for this role include:
  • Bachelor\xe2\x80\x99s engineering degree with 10+ years of experience / Master\xe2\x80\x99s degree with 5 years of experience; preferably in Mechanical-, Electronics Engineering role in the medical or aerospace industry.
  • Experience with SAP is preferred.
  • You are very meticulous; having a great eye to detail and are very careful and precise in your executions.
  • Experience in design control; and especially design change management for medical devices.
  • Able to define and re-confirm Quality and Reliability target for medical product changes to assure their continued Safety, Effective and Reliable.
  • Ability to contribute to Risk Management and lead FMEA activities for intended changes and assurance that control measures are translated in appropriate (critical) requirements.
  • Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing.
  • Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
  • Experience with adequate and accurate review of DHF and DMR documents.
  • Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.
  • Experience with working in multidisciplinary teams in a high-tech R&D environment.
  • Effective interpersonal, written and oral communication skills expected.
  • Ability and willingness to work in office as per local policy; currently being at least 3 days per week.
Why should you join Philips? Working at Philips is more than a job. It\xe2\x80\x99s 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. To find out more about what it\xe2\x80\x99s 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. How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart \xe2\x80\x93 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home \xe2\x80\x93 for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There\'s a certain energy when everyone\xe2\x80\x99s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn\xe2\x80\x99t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips?
Working at Philips is more than a job. It\xe2\x80\x99s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

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Job Detail

  • Job Id
    JD3243163
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Pune, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year