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

• Perform work with little to no supervision as department subject-matter expert

• 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, good to have Master’s degree.

• 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.

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