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Philips System Validation Architect India, Maharashtra 904158544
You are responsible for
Supporting product Validation through the phases of the Medical Device lifecycle.
Providing technical support and leadership on a cross-functional team
Define, document, and continuously improve Validation tests including conducting peer reviews and maintaining traceability to requirements
Perform Validation tests and conduct analysis of the test results to ensure complete Validation 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 Validation 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.
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 15+ years’ experience with Minimum 7 years of experience in medical device validation 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 medical devices. (FDA CFR Title 21, 820.30)
Experience specific to product Validation.
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.
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:
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