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IFU Instructions for Use Product Owner
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#338345
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Job type
Full-time
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Work from home
Benefits
Pulled from the full job description
Work from home
Full Job Description
Job Title
IFU (Instructions for Use) Product OwnerJob Description
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. 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 state-of-the-art standards and regulations (e.g. IEC, ISO, FDA standards), international and country-specific 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 re-use, consistency and harmonization across products to deliver customer experience.
Take part in the IFU Review process, taking ownership in content-related 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 co-operation 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 of tasks.
Collaborate and communicate effectively with cross-functional teams including Localization, Product/Project Management, Engineering, Quality and Regulatory, to produce high-quality 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 working in a highly regulated industry and following mandatory processes (healthcare, automotive, aviation…)
Ability to prioritize work, balance multiple projects concurrently, and meet strict deadlines.
Desirable
Experience working as a technical author, writing content for software and hardware products
Knowledge and/or experience using Tridion Docs or ST4
Experienced in XML based CCMS and with publishing to PDF and HTLM5
Experience with or knowledge of localization and its process.
Regulatory knowledge
Experience working with medical devices/products.
Strong interpersonal, communication, attention to detail, organizational, and 'self-starter' skills
First-class analytical and problem-solving skills with a dedication to maintaining high quality standards.
In return, we offer you
A chance to serve a bigger purpose. At Philips, our mission to improve the lives of 2 billion people per year by 2026, 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 cutting edge 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.
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 - 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 - 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:
There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
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's 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.
#LI-PHILIN
12.00-15.00 Years
No matching job preferences
Job type
Full-time
Benefits & Perks
Work from home
Benefits
Pulled from the full job description
Work from home
Full Job Description
Job Title
IFU (Instructions for Use) Product OwnerJob Description
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. 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 state-of-the-art standards and regulations (e.g. IEC, ISO, FDA standards), international and country-specific 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 re-use, consistency and harmonization across products to deliver customer experience.
Take part in the IFU Review process, taking ownership in content-related 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 co-operation 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 of tasks.
Collaborate and communicate effectively with cross-functional teams including Localization, Product/Project Management, Engineering, Quality and Regulatory, to produce high-quality 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 working in a highly regulated industry and following mandatory processes (healthcare, automotive, aviation…)
Ability to prioritize work, balance multiple projects concurrently, and meet strict deadlines.
Desirable
Experience working as a technical author, writing content for software and hardware products
Knowledge and/or experience using Tridion Docs or ST4
Experienced in XML based CCMS and with publishing to PDF and HTLM5
Experience with or knowledge of localization and its process.
Regulatory knowledge
Experience working with medical devices/products.
Strong interpersonal, communication, attention to detail, organizational, and 'self-starter' skills
First-class analytical and problem-solving skills with a dedication to maintaining high quality standards.
In return, we offer you
A chance to serve a bigger purpose. At Philips, our mission to improve the lives of 2 billion people per year by 2026, 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 cutting edge 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.
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 - 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 - 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:
There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
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's 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.
#LI-PHILIN
12.00-15.00 Years
