Job Description

[ n Your Job xb7 xa0xa0xa0xa0xa0xa0 A challenging position in an international innovative and successful company that is growing. xb7 xa0xa0xa0xa0xa0xa0 An opportunity to setup the processes and development team in India to support the Indian customers. xb7 xa0xa0xa0xa0xa0xa0 An opportunity to become part of a global team of dedicated and highly qualified colleagues based in Bangalore, India. xb7 xa0xa0xa0xa0xa0xa0 Well-structured training and continuous development of your competencies. xb7 xa0xa0xa0xa0xa0xa0 Exciting career possibilities within the constantly growing area of medical devices xb7 xa0xa0xa0xa0xa0xa0 Salary on a competitive level. Our Team Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region. What You Will Do xb7 xa0xa0xa0xa0xa0xa0 Primary ownership of Risk management process for a medical device as per ISO 14971 standards xb7 xa0xa0xa0xa0xa0xa0 Define life-cycle phases of risk management activities based on product lifecycle encompassing conceptualization, design & development, manufacturing, in-use, disposal. xb7 xa0xa0xa0xa0xa0xa0 Perform Risk Analysis that involves systematic identification of failure modes that can lead to hazardous situation from a potential hazard xb7 xa0xa0xa0xa0xa0xa0 Work with clinician to identify harms that can result from a hazardous situation. xb7 xa0xa0xa0xa0xa0xa0 Work with subject matter experts in usability, Engineering, manufacturing to develop usability, design, Process risk assessments. Possess Working knowledge in FMEA xb7 xa0xa0xa0xa0xa0xa0 Identify the essential performance requirements, Sub-System specifications as risk control measures. xb7 xa0xa0xa0xa0xa0xa0 Integrate the product safety standards requirements into product design input requirements. xb7 xa0xa0xa0xa0xa0xa0 Perform the Benefit- risk analyses. xb7 xa0xa0xa0xa0xa0xa0 Evaluate that risk control measures that are taken are effective by reviewing the verification reports xb7 xa0xa0xa0xa0xa0xa0 Review the DHF files related to risk management process. xb7 xa0xa0xa0xa0xa0xa0 Generate risk management report summarizing the outcome of risk management process. xb7 xa0xa0xa0xa0xa0xa0 Monitor the customer complaints, Perform Similar devices safety screening reports to check for unidentified risks xb7 xa0xa0xa0xa0xa0xa0 Acts as subject matter experts for product development team to incorporate risk management principles. xb7 xa0xa0xa0xa0xa0xa0 Ensure that Risks are reduced to acceptable level by working across functions. Who You Are (Basic Qualifications) xb7 xa0xa0xa0xa0xa0xa0 Graduate/Post graduate in Mechanical engineering/Electrical engineering. xb7 xa0xa0xa0xa0xa0xa0 Have 8+ years of experience in xa0 medical device risk management and device reliability xb7 xa0xa0xa0xa0xa0xa0 Proficient with the use of ISO 14971 for risk management process of a medical device xb7 xa0xa0xa0xa0xa0xa0 Proven Track record for implementing risk management in a medical device xb7 xa0xa0xa0xa0xa0xa0 Experience in working risk management for class II, Class III medical device xb7 xa0xa0xa0xa0xa0xa0 Working knowledge in the use of Root cause analysis tools such as Cause-effect diagrams, FMEAS, Fault-tree diagrams etc. xb7 xa0xa0xa0xa0xa0xa0 Good understanding of Quality Management Systems. (ISO 13485, 21 CFR 820) xb7 xa0xa0xa0xa0xa0xa0 Thorough understanding of design controls of medical devices What Will Put You Ahead xb7 xa0xa0xa0xa0xa0xa0 Having hands on experience in FMEA tools such as Sphera FMEA, Stature etc xb7 xa0xa0xa0xa0xa0xa0 Proficient with the use of various reliability prediction probability models such as Weibull, normal, Exponential etc xb7 xa0xa0xa0xa0xa0xa0 Proven track record for reliability prediction of a medical device At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate\'s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy. Who We Are At Koch, employees are empowered to do what they do best to make life better. Learn how ourxa0xa0helps employees unleash their potential while creating value for themselves and the company. n ]

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