Prin Software Quality Engr - Bangalore - Medtronic
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Medtronic is the world’s largest medical technology company, offering innovative therapies and solutions to fulfill our Mission of alleviating pain, restoring health, and extending life. Medtronic’s Renal Care Solutions (RCS) business unit has the vision of improving outcomes, access and quality of life for patients affected by kidney disease by offering a full range of affordable products, services and solutions. One of the products currently being developed at RCS is a novel kidney dialysis solution aimed at patients suffering from end-stage renal disease, and to address key infrastructural barriers, in emerging markets. The Medtronic India Development Center (MIDC) in Bengaluru is an integral part of global R&D at RCS, and is looking to hire talented candidates to work on exciting opportunities. See here for more details about MIDC: http://www.medtronic.com/in-en/about-3/research-development.html
The candidate for this position will lead the execution of Software Quality assurance for any new product development or sustaining products. This involves ensuring adherence to and helping define the Medtronic Quality Systems, being a subject matter expert in quality requirements of the medical device industry and providing guidance to the business in interpreting and executing the Medtronic Quality system elements to ensure compliance.
This individual will ensure that all Software and Firmware related needs across the SDLC meet Medtronic’s quality, reliability, and compliance requirements. He/she will be required to closely partner with SW and FW design and test teams within global RCS R&D, and also at external engineering service providers.
Create and maintain SW and FW quality and performance requirements and the related metrics
Contribute to test method creation , review and approve test protocols to support V&V activities for Software and Firmware team.
Leads risk assessments and develop/maintain risk management files for SW, FW, SOUP and Tools
Actively participate in product development cycle by ensuring that design control processes are followed, reviewing product project documentation and owning the closure of the defects.
Partner with cross functional teams and function seamlessly within the Global Quality team.
Lead resolution to post-market product defects, complaints, and/or safety issues
Lead adherence to processes for technical design reviews, code reviews and CCB (Change Control Board) reviews, active member of the Defect Review Board.
Own quality of technical design reviews, code reviews and CCB (Change Control Board) reviews.
Assess quality programs and systems with relation to standards such as IEC 60601-1 and IEC 62304 , ISO 13485 and ensure adherence to the standards
Drive SOP updates or creation of new processes based upon upcoming standards or process improvements
Assist in vendor audits to ensure the quality of the vendor deliverables , assist in internal audits and prepare the team for facing the audits
Create a culture of quality awareness/focus by mentoring junior engineers and conducting training sessions
Champion of product quality
Bachelor’s degree (or higher) in Software/ Computer Engineering, or equivalent.
12+ years of experience in an engineering role.
Expertise in various phases of SLDC and quality requirements/standards for medical device industry.
Hands on experience with risk analysis, risk management, requirements traceability, and Fault Trees or dFMEAS
Experience in conducting DHF Audits, Milestone review checks and process compliance audits
Strong verbal and written communication skills; ability to produce high-quality documentation.
Ability to work independently, self-starter and accountable, with sharp focus on quality and customer experience.
Ability to work in cross-functional and cross-cultural global teams; Ability to participate in early morning and/or late night calls; Ability to travel domestically and internationally as required
Experience working on embedded systems (Firmware development)
Working knowledge of Android, Java, C, C++
Knowledge on working using Agile methodologies preferably Scrum.
Skilled in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes
Experience with requirements management, version control, and issue tracking tools
Working knowledge Six Sigma