Prin Reliability Engineer - Bangalore - Medtronic
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As a global leader in medical technology, services and solutions, Medtronic improves the lives and health of millions of people each year. We use our deep clinical, therapeutic and economic expertise to address the complex challenges faced by healthcare systems today. Let’s take healthcare Further, Together. Learn more at www.medtronic.com .
Medtronic’s Renal Care Solutions (RCS) business unit is currently developing a novel kidney dialysis solution aimed at patients suffering from end-stage renal disease, and to address key infrastructural barriers, in emerging markets. As part of this initiative, RCS has established the Medtronic India Development Center (MIDC) in Bengaluru, and is looking to hire talented candidates to work on exciting opportunities.
More details at : http://www.medtronic.com/in-en/about-3/research-development.html .
The candidate for this position will be part of the global Quality team for the RCS business unit, and work on new product development and pre- and post-market reliability engineering for electromechanical medical devices. The candidate will define reliability goals and strategy for new products developed. The candidate will be responsible for developing test protocols to meet the reliability strategy defined and test the product to ensure that reliability requirements are met. The candidate will also support engineering team to determine design margins for product designed through methods like de-rating analysis.
You will work in collaboration with a global team based in India, China and USA (including Medtronic colleagues and local and international engineering services providers), throughout the product development lifecycle to bring new products to market. You will need to be comfortable dealing with ambiguity, and be confident about combining technical expertise with logical reasoning to make trade-offs between test methodologies, time-to-market, and budget. You should have an entrepreneurial spirit, a can-do attitude, and possess great communication/collaboration skills.
· Lead component, subsystem, and system level reliability testing including life testing, demonstration testing, and HALT
· Lead field replacement component/subsystem strategies for new products
· Lead reliability improvements in Renal Care Solutions products by focusing on product design
· Work with cross-functional team to ensure Design for Reliability (DFR)
· Leverage reliability software tools to facilitate comprehensive set of reliability engineering modeling and analysis techniques to drive DFR
· Lead warranty cost optimization efforts for new products
· Post-market reliability : Analyze technical performance of the products in the field, lead root-cause analysis of failures, participate in CAPA investigations
· Bachelor of Engineering degree from a reputed university (Mech / Elec / Biomedical / Software)
· 12+ years of total work experience in design, test/V&V or quality/reliability roles in development of multidisciplinary technical products (biomedical, electromechanical, hardware-software, etc.)
· Experience working in all phases of the product development lifecycle (conceptualization, prototyping, design completion, commercial release, and cost-down/continuous improvement)
· 5+ years’ experience in the healthcare domain, with knowledge of medical device-related standards such as ISO 13485, US FDA’s 21 CFR 820, IEC 60601, etc. OR in a regulated industry such as aerospace or automotive
· Strong competency in statistics and expertise in analysis tools such as Excel, Minitab, Crystal Ball, Reliasoft suite of products or equivalent.
· Experience with returned product analysis
· Demonstrated ability to complete complex technical tasks on time, by providing strong technical leadership and guiding/coaching early-career engineers
· Excellent verbal and written communication skills, strong critical thinking and influencing skills
· Ability to work with cross-functional and cross-cultural global teams, and participate in early morning and/or late evening conference calls. Occasional travel, based on project needs.
· Master’s degree in Engineering
· Relevant certifications (Reliability Practitioner, ASQ, Lean or Six-Sigma Green / Black Belt
· Formal training in development methodologies such as “Design of Experiments”
· Knowledge of de-rating analysis/ design margin analysis for electromechanical products
· Experience in software reliability testing methodologies
· Basic understanding of multiple technical fields. E.g. if you are a mechanical engineer, it would be a bonus to also have working knowledge of electrical/software/biomedical engineering
· Understanding of fluid circuits and flow control mechanisms (pumps, valves, heaters, sensors, etc.)