Sr Quality Engineer

Year    Bangalore, Karnataka, India

Job Description


Careers that Change Lives Medtronic is the world\'s largest medical technology company, offering an unprecedented breadth and depth of innovative therapies to fulfill our Mission of alleviating pain, restoring health, and extending life. Medtronic 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, Medtronic\'s Renal Care Solutions group has established the Medtronic India Development Center (MIDC) in Bengaluru and is looking to hire talented candidates to work on exciting opportunities. This position is an exciting and new opportunity that is currently part of Medtronic and will move to a to-be-named company we are calling \'Mozarc Medical\'. Mozarc Medical will be an independent company with equal partners, Medtronic & DaVita. It will be established in calendar 2023 as a new company (Mozarc Medical) formed from Medtronic\'s Renal Care Solutions Operating Unit focused on providing innovative technologies to support kidney care patients. While you start your employment with Medtronic, upon establishment of Mozarc Medical your employment will transfer to Mozarc Medical and you will no longer be employed by Medtronic. Mozarc Medical is uniquely poised to transform renal care and dialysis, building on Medtronic\'s innovation and technology pipeline. The business will have the singular focus, financial commitment, deep domain expertise, and global footprint needed to accelerate the development and commercialization of affordable and scalable life-saving renal care technologies - particularly our transformative home dialysis platform technologies. A Day in the Life A Day in the Life as a Sr Reliability Quality Engineer/Consultant within Mozarc Medical team, you will play a key role improving reliability and quality of complex electro-mechanical and software systems, working with globally distributed teams in order to provide innovative technologies to support kidney care patients. . Participates in establishing and reviewing specifications/requirements for components, products, and processes . Analyzes complex issues considering reliability statistics and clinical impact . Collaborates with engineering team and reliability team to run technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs . Reviews, and approves Reliability Design Testing Plans and Reports. . Recommends and implements design or test methods and statistical process control procedures for achieving required levels of product reliability . Collaborates to risk analysis studies of new design and processes . May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data Must Have: Minimum Requirements . B.E or B.Tech or Master in engineering with specialization in Mechanical/Electrical/Electronics/Software/ with 8 to 12 years of Quality and Reliability Engineering experience. . Medical industry or regulated industry experience . Solid understanding of Reliability processes from early development to post launch . Test process and problem solving skills . Excellent oral and written communication skills . Technical knowledge of complex software based electro-mechanial systems . Understanding of technical principles, theories , techniques and engineering test protocols . Experience using Reliasoft and/or Minitab . Experience with statistical analysis (Monte Carlo simulation, Reliability/survivability statistics, and Bayesian statistics) or reliability engineering. Experience with one or more of the following types of medical devices/systems: . Reviews software systems design, change specifications, and plans against contractual and/or process requirements. . Reviews include applicable specifications, materials, tools, techniques, and methodologies. . Provides or directs verification and validation of software system requirements, traceability, and testability. . Experience and familier with Implementation ofISO 13485 , ISO 14971,QSR 820 and EU MDR requirements as and when needed. . Ensure IEC 62304 requirements are met as part of Software life cycle development and deployment with devices. Principal Working Relationship . Reports to the Site Quality Leader and or Principal QE & above. . Working closely with global stakeholders, Design Quality engineers, R&D engineers. Reliability Engineers, Systems engineers and Quality team . . Participate in the various technical meetings and contribute. . Collaborate and coordinate activities with globally distributed teams, ensuring overall product quality. . Drive Reliability process and ensure Implementation. Nice to Have . Certification in Reliability Engineering (ASQ) or similar courses in school . Six Sigma certification . Statistical Tools : MINITAB, SPC . Project Management experience . Reusable Capital Equipment . Dialysis tubing Your Answer Is this the position you were waiting for Then please apply directly via the apply button!

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Job Detail

  • Job Id
    JD3165566
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bangalore, Karnataka, India
  • Education
    Not mentioned
  • Experience
    Year