Job title: Product Validation Engineer
Company: Philips
Job description: Job Title Product Validation Engineer
Job 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 Driving the design validation strategy and evidence collection throughout our projects, to ensure the product release meets customer, regulatory and business needs. Regulatory and business requirements are more and more demanding, which requires validation with sound scientific evidence.
You are responsible for
Design validation strategy in an assigned R&D project i.e. design validation plan, traceability & evidence collection
Budgeting & coordination of design validation resources including test systems, validation engineers and recruitment costs
Domain expertise in algorithm and claim validation
Stakeholder management with functions in Clinical Science, Clinical Marketing, Innovation and Research, to keep up to date with innovations in imaging technology and to ensure clinical studies fit the evidence needs of our running projects.
Additional Responsibilities:
Ensure that quality system requirements concerning software and computer system validation are effectively established and maintained following regulations and guidance, as applicable.
Responsible for the overall validation strategy for new and existing computer systems throughout the entire system development lifecycle.
Develop, lead, and own the process/procedures for System Validation, Infrastructure and Tools Qualification.
Review and approve system documentation (including System Validation Plan, User Requirements, Validation Test Protocols, Trace Matrix, Risk Assessments and Validation Summary Report) in support of validation activities.
Work closely with cross-functional teams to document User Requirements and Functional Specifications. Perform Risk Assessment. Develop Computer System Validation Plan(s) that is appropriate for the system risk level.
Develop Test Plans and Deliver Validation Protocols (including Installation Qualification, Operation Qualification, and Performance Qualification). A review of executed Validation Protocols and ensure supporting test documentation complies with FDA regulations.
Develop a Validation report with a summary of test results. Review Change Control and Change Assessment to ensure the system remains validated.
Develop training material for System Validation and execution. Defend and support quality management and quality design practices during FDA audits. Identify compliance gaps and trends and develop and execute strategies to mitigate the gaps efficiently and effectively.
You are a part of Connected Care cluster organization focusing on development of mechanical and electrical designs for a common platform serving multiple product lines. Healthcare Innovation Center (HIC) is playing a key role in Philips global strategy for Connected Care businesses.
At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.
To succeed in this role, you’ll need a customer-first attitude and the following
Bachelors or Masters degree in Engineering
Minimum 5+ years of related experience
Knowledge of design controls and international standards & regulations (IEC62304, ISO13485, ISO14971)
Proven project management skills in managing multiple stakeholders and projects
You are a self-starter, quality-conscious, excellent communicator, problem solver and team player
Understanding of research methodologies and clinical study design according to good clinical practices
Excellent communication and writing skills in English
ADDITIONAL QUALIFICATIONS:
Bachelor’s degree in Chemistry, Genomics, Molecular Biology, Pharmacy/Pharmaceutical Engineering, Computer Science, Software Engineering, or related field, followed by five years of progressive, post-baccalaureate work experience in the job offered or position-related occupation.
Position requires:
5 years of experience leading validations of various types of software applications, including writing and reviewing/approving process documents such as SOPs/Work Instructions, computer validation documents in a Medical Device, Pharmaceutical, or Biologics environment in the areas of Quality Assurance, Compliance, Information Technology, and Manufacturing.
Knowledge of FDA, European Union, and GxP regulatory requirements, including 21 CFR Part 11/Annex 11, ISO 13485/14791, ICH Q9, from a Governance, Risk, and Compliance perspective. (5 Years).
SDLC methodologies, including Waterfall, V-Model, and Agile risk-based model. (5 years);
Validation experience is a must
Technical experience in medical device applications. (5 years);
Regulatory and vendor audits.
Quality risk management techniques and tools (e.g. FMEA, SRA, etc.);
Data governance/Integrity/life cycles and management.
Organizational, management and leadership skills.
In return, we offer you a challenging, innovative environment with great opportunities to explore. Our benefits are very competitive and designed around your preferences:
A rewarding career in Philips with attractive package.
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
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:
We believe in the importance of impactful collaboration: There’s a certain energy when everyone’s 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’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.
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’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.
To find out more about what it’s like working for Philips at a personal level, visit the on our career website, where you can read stories from our . Once there, you can also learn about our , or find answers to some of the .
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Expected salary:
Location: Pune, Maharashtra
Job date: Thu, 12 May 2022 23:32:35 GMT
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