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medical device @ Idexcel

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 medical device

Job Description

Role & responsibilities


Experience : 5+yrs

Location: Preferably Mysore/ Ok for Bangalore


Mandate  skills: reliability test Medical Device

JD:

- Develop and execute reliability test plans (e.g., accelerated life testing, HALT/HASS, stress testing)

- Conduct Failure Mode and Effects Analysis (FMEA) and root cause investigations

- Collaborate with R&D to integrate reliability into product design

- Analyze test data using statistical methods (Weibull, ANOVA, DOE)

- Maintain and update Design History Files (DHF) and risk documentation per FDA and ISO standards

- Ensure compliance with ISO 13485, ISO 14971, and FDA 21 CFR 820.30

- Support design verification and validation activities

- Provide technical guidance during audits and regulatory submissions

Job Classification

Industry: IT Services & Consulting
Functional Area / Department: IT & Information Security
Role Category: IT & Information Security - Other
Role: IT & Information Security - Other
Employement Type: Full time

Contact Details:

Company: Idexcel
Location(s): Mysuru

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Keyskills:   Reliability Testing FMEA compliance Medical Devices reliability test plans DHF

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Idexcel

Idexcel Technologies Private Limited Idexcel is a Professional Services and Technology Solutions provider specializing in Cloud Services, Application Modernization, and Data Analytics. Idexcel is proud that for more than 21 years it has provided services that implement complex technologies that ...