Ifu (Instructions for Use) Product Owner

1 week ago

Pune, Maharashtra, India Philips Full time

Job Title:
IFU (Instructions for Use) Product Owner


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's not just what we do, it's 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' needs.

It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.


The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more.

That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.


In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips' purpose has never been more relevant.

So whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.

Be responsible for coordinating and supporting activities which lead to the realization, translation and delivery of Instructions for Use (IFU) documentation of IGT products throughout the product creation process, ensuring that the product release meets regulatory, customer and business needs, be responsible for coordinating and supporting activities which lead to the realization, translation and delivery of Instructions for Use (IFU) documentation of IGT products throughout the product creation process, ensuring that the product release meets regulatory, customer and business needs

You are responsible for

  • Analyze stateoftheart standards and regulations (e.g. IEC, ISO, FDA standards), international and countryspecific requirements and determine the impact for Instructions for Use documentation accompanying medical products to be delivered globally
  • Define and maintain the IFU (Instructions For Use) Roadmap, describing the plan for future activities around the IFU based on trends in areas of content, supporting processes and tools, suppliers and associated areas
  • Create IFU Requirements Specifications for the products of IGT Systems, manage the realization in actual IFUs, with focus on reuse, consistency and harmonization across products to deliver customer experience.
  • Take part in the IFU Review process, taking ownership in contentrelated discussions with reviewers, advising the technical writers on implementation aspects in the actual IFUs
  • Take part in internal as well as Philips level Control Boards, defining the IFU creation process and handling practical implementation issues across the different disciplines involved in the IFU creation up to and including delivery to the customer and actual use by the customer
  • Ensure a good cooperation with stakeholders e.g. System Design, Regulatory and Norm Compliance representatives
  • Create and maintain a network with other technical product owners as well as with IFU creation departments in other Philips business units and outside Philips.
  • Actively participate in project team meetings and estimating the relative size of tasks.
  • Collaborate and communicate effectively with crossfunctional teams including Localization, Product/Project Management, Engineering, Quality and Regulatory, to produce highquality and accurate customer documentation that complies with regulatory requirements and standards.
  • Draft the new and updated English IFUs (optional, in case technical writer are not doing this:
  • Use technical writing tools (e.g. CCMS Tridion Docs etc.)
  • Consult with SMEs to refine and improve drafts
  • Hold design reviews to approve draft English IFUs
  • Release final IFU versions as per IGT quality system.

You are a part of the Design Validation team within the R&D Department of the Image Guided Therapy (IGT) Business within Philips Healthcare. This Business Unit is responsible for marketing, service, development, and manufacturing of IGT systems used in the area of cardiac or vascular medical diagnosis and treatment (e.g. balloon angioplasty and stent procedures). Customers are interventional specialists, in the cardiology and radiology domain operating in a wide variety of hospitals across the globe.

The team you will be working in is a high-performance, culturally diverse team working in a dynamic environment. The team is approx. 10 persons working in the areas of Usability, Design Validation, Process Improvement, and Instructions for Use.

To succeed in this role, you'll need a customer-first attitude and the following
Essential

  • Bachelors Degree in Enginering with 12+ years of relevant work experience in IFU Documentation
  • Fluent English (written and verbal)
  • Proactive approach in developing content
  • Can do mentality
- ** Experience w

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