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System Test Designer (System V&V) - Medical Devices
10-15 years
Pune
1 vacancy
System Test Designer (System V&V) - Medical Devices
Philips
posted 19hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.
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.
Employment Type: Full Time, Permanent
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What people at Philips are saying
Rating based on 5 Test Designer
reviews
Anonymous · Engineering - Software & QA
in Pune
Likes
Philips culture and flexible timing
- Salary - Good+6 more
Dislikes
Need to work on latest technologies
Test Designer salary at Philips
reported by
13
employees
with 7-16
years exp.
₹17
L/yr - ₹23.4
L/yr
64%
more
than the average Test Designer Salary in India
View more details
What Philips employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Philips Benefits
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Philips Pune Office Location
Pune Office
Philips Medical System, No.6, 2nd Floor, Dinkar Smruti, Shivajinagar, Bhamburda
Pune
Maharashtra 411005
Maharashtra 411005
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