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
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
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
Working knowledge of Android, Java, C, C++
Knowledge on working using Agile methodologies preferably
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