Design Quality Engineer II

Medtronic

4 - 6 years

6 - 8 Lacs

hyderabad

Posted:2 weeks ago| Platform:

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Skills Required

product management medical devices software design iso 13485 healthcare product design firmware pfmea risk management hazard analysis

Work Mode

Work from Office

Job Type

Full Time

Job Description

A Day in the Life Design Quality engineer for Tool packages to support Stealth station

Careers that Change Lives

This position is for design quality engineering support of software design and development of medical devices, stand-alone software of non-products, non-devices and components including firmware. Facilitate the application of design controls in product development and released product management.

A Day in the Life

Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Capable of mentoring junior quality engineers in providing quality engineering support

Must Have

Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, FDA Quality System Regulations, EU MDR and inhouse Standards.
Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA
Ensure successful transfer of new products to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
Strong in software design and development, software verification and validation activities
Review Design History Files and Technical Files for conformance to applicable requirements.
Participate when appropriate in audits
Demonstrates mastery of software development and testing methodologies
Independently develops test strategies for new, pre-concept features in development.
Ensures applicability to SOUP / OTS validations in the product development
Participates on CCB to decide upon CR implementation.
Assesses the compliance of the software development methodology to the approved process.
Participate and provide input to training on department / procedures and policies
Hands-on experience on Software Risk Management, Design Controls.
Facilitates hazard analysis and SFMEA sessions. Prepares the risk management file.
Acts as the subject matter expert on risk management for one or more products/platforms.
Applies quality system regulations, applicable standards and guidance to multiple projects
Develop templates and training based on the quality system regulations, applicable standards and guidance.
Independently reviews all SW deliverables to ensure compliance with development process and the standard.
Deliver presentations to the QA organization on status and issues of assigned projects. Deliver training to departments outside of QA.
Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
Previous experience working in a cross-functional team environment.
Provide Quality support to facilitate resolution of product complaints and/or safety issues
Provide support to the Regulatory Department in writing technical submissions.
Minimum Qualification
B E or B. Tech
Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience

Medtronic offers a competitive Salary and flexible Benefits Package

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