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Senior system test Engineer

4 months ago

Pune, India Philips Full time
Job TitleSenior system test Engineer

Job Description

Job title:
Senior System Test Eng

Your role:

  • 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, owning, and driving technical issues to resolution
  • Perform work with little to no supervision as department subject-matter expert
  • Leads 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 fixtures
  • Keeps 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 activities.
  • Provides technical leadership to ensure overall product development success.

.

You're the right fit if:

  • Bachelorâs degree in Electrical/Electronics/Mechanical/Biomedical Engineering or related field. Masterâs degree is preferred.
  • Total 12+ yearsâ experience in systems V&V with Minimum 5 years of experience in medical device.
  • 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.
  • Hands on experience of remediation projects for FDA or EUMDR.
  • Solid understanding of medical device product development, preferably Design Control experience with Class II and III medical devices.  (FDA CFR Title 21, 820.30)
  • Experience specific to product verification.
  • Experience on V&V of ventilator will be preferred.
  • Hands on experience of test method validation.
  • Experience on useful life testing will be preferred.
  • Experience on C&D testing will be preferred.
  • Experience in designing and assessing compliance to national/international standards.
  • Strong technical writing/ documentation skills for regulated medical device design environment, including requirements definition
  • Demonstrates 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.



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If youâre 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 commitment to diversity and inclusion here.

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