Bangalore, India
3 days ago
V&V Architect - Medical Devices
Job TitleV&V Architect - Medical Devices

Job Description

Emergency Care Business:

In late January, we announced that Bridgefield Capital signed an agreement to acquire Philips’ Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025. 

With Bridgefield’s support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments.

V&V Architect - Medical Devices

In this role, you have the opportunity to

Be an integral part of the Emergency Care and Resuscitation (ECR) R&D leadership team, actively participating in cardiac defibrillator product development. ECR team has a broad product portfolio of advanced life support solutions, automated external defibrillators, and data management solutions.  Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers – from clinicians to paramedics, first responders to the everyman – to save lives using our innovative, market-leading technology.

We are looking for a passionate Verification & Validation Architect to join us as we strengthen our product portfolio, expand our services and solutions, and bring game-changing technology to market. This team member will be responsible for working collaboratively with a team of cross-functional engineers.

Your role:

Supporting product verification through the phases of the Medical Device lifecycle.Providing technical support and leadership on a cross-functional teamDefine, document, and continuously improve verification tests including conducting peer reviews and maintaining traceability to requirementsPerform verification tests and conduct analysis of the test results to ensure complete verification of the requirementsIdentifying, analyzing, owning, and driving technical issues to resolutionPerform work with little to no supervision as department subject-matter expertLeads and participates in design reviews, including reviews of design verification plans, reports, and test artifacts.Work with design teams to isolate design errata, perform failure analysis, and verify design fixes.Development and execution of validation test plans , test records and Test fixturesKeeps abreast of new developments in all relevant technological domains.Advises on change requests for system and related products.Provides technical leadership to ensure overall product development success.Keeps abreast of new developments in all relevant technological domains.Contributes to technology roadmaps and other strategic related activitiesProvides technical leadership to ensure overall product development success.

You're the right fit if:

Bachelor’s degree in Electrical/Electronics/Mechanical Engineering or related field. Master’s degree is preferred.Total 12+ years’ experience with Minimum 8 years of experience in medical device or other similar industryDemonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.Solid understanding of medical device product development, preferably Design Control experience with Class-III medical devices (FDA CFR Title 21, 820.30).Experience specific to product verification.Experience in designing and assessing compliance to national/international standards.Strong technical writing/ documentation skills for regulated medical device design environment, including requirements definitionDemonstrates strong results orientation: This position requires the proven ability to consistently meet and/or exceed goals. The successful candidate must be capable of making commitments, setting priorities, and delivering results on time and on budget.Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.Possess strategic agility/vision:  Sees ahead clearly; can anticipate future concerns.Develops and maintains effective relationships and is capable of quickly earning trust and respect.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office-based role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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