System Test Designer

1 week ago

Pune, India Philips Full time

**Job Title**: System Test Designer (Mechanical V&V) - Medical Devices

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**

We are looking for a passionate System Test Designer 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.

**You are responsible for**
- Supporting product verification through the phases of the Medical Device lifecycle.
- Providing technical support and leadership on a cross-functional team
- Define, document, and continuously improve verification tests including conducting peer reviews and maintaining traceability to requirements
- Perform verification tests and conduct analysis of the test results to ensure complete verification of the requirements
- Identifying, analyzing and driving technical issues to resolution
- Participates in design reviews, including reviews of design verification plans, reports, and test artifacts.
- Development and execution of validation test plans, test records and Test fixtures
- Keeps abreast of new developments in all relevant technological domains.
- 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 activities
- Provides technical leadership to ensure overall product development success.

**You are a part of**

This position resides in EC (Emergency Care and Public Access) Business Category within the Connected Care Cluster. Emergency Care is expanding access to and quality of respiratory care, resuscitation, and emergency care solutions (including devices, services, and digital/data solutions). We are the number one provider of therapeutic care solutions, saving and improving more and more lives every year.

This role will be based in our Pune office and will report to the Emergency Care R&D Leader in Pune, India. This is a very exciting time to be joining Philips, as this new location will be emerging as a strong engineering team in Emergency Care product development

**To succeed in this role, you should have the following skills and experience**
- Bachelor’s degree in Electrical/Electronics/Mechanical Engineering or related field. Master’s degree is preferred.
- Total 10+ years’ experience with Minimum 5 years of experience in medical device or other similar industry
- Demonstrated 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/Class-3 medical devices (FDA CFR Title 21, 820.30).
- Experience specific to product verification.
- Solid understanding of System Verification and Validation test plan/protocols, executing V&V activities, generating, and analyzing test reports
- Experience in designing and assessing compliance to national/international standards.
- Strong technical writing/documentation skills for regulated medical device design environment, including requirements definition
- 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 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 ba

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