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iTrace invites Applications from Product Development Engineer – Medical Devices Currently, we have exciting job opportunities for talented and self-motivated scientists/engineers to join our foundation team. We offer attractive salaries, incentive stock options, challenging and fun filled work environment for highly qualified individuals. The job position and compensation will be commensurate with your prior work experience, credentials and qualifications. To apply and to learn more about the positions available, please send your up-to-date CV to humanresource@itrace.co.in   Sr. Product Development Engineer - Medical Devices (PDE-01) JOB RESPONSIBILITIES Perform research and development activities utilizing engineering principles. Develop prototype designs, testing methods, procedures and testing as directed. Provide written documentation and reports for testing support the team with clinical trials by providing engineering input Collaborate/coordinate with scientists/engineers in academic institutions/contract laboratories to advance research activities in the fast paced start up environment. Update estimates, schedules, budgets, reports and design control documents based on revisions and changes to product designs and research projects Actively participate in rapid commercialization of first generation medical device and related activities. Apply strong analytical skills and good sense of judgment Work effectively as an independent researcher and as a collaborate with research and development, quality, manufacturing, regulatory, sales and marketing, outside vendors, and others to accomplish assigned tasks. Complete the projects on time and demonstrate leadership skills Maintaining the quality to ensure compliance as per the appropriate ISO/FDA regulations for the design, testing, documentation, and manufacturing of the company's products. Generate test plans and reports in support of regulatory submissions Document all the technical advances and discoveries by timely filing the reports and invention disclosures. Give scientific updates, presentations and make recommendations regarding technology advancement to the management team. DO YOU HAVE IT? Mandatory Qualifications Masters in Bio-medical/ Electronics/ Mechanical/ engineering or related field with experience in developing portable medical devices. Candidates with advanced degrees or demonstrated industry experience will be given priority. Minimum of 2-5 yrs of medical device industry experience in a product development engineering position Experience in developing portable medical devices with a thorough understanding of industrial design/human interface is desirable. Experience in taking the product from the proto-type stage to commercialization Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products Demonstrated ability to work effectively and collaboratively in a technical and cross-functional team and ability to assume leadership responsibilities. Experience in generating test plans, writing protocols, and conducting design verification/validation and process validation testing Experience with CAD, and other product design softwares. Experience in risk assessments for product and processes (Failure Mode Effects Criticality Analysis (FMECA)), complying with ISO 14971. Experience/familiarity with U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices Excellent oral and written communication skills. Desired Skills Strong background in medical device product development in R&D environment     iTrace Nanotech Pvt. Ltd. Corporate office: A1, Vikrampuri, Secunderabad - 500 009, India www.itrace.co.in Labs: ICICI Knowledge Park, Genome Valley, Turkapally, Shameerpet, Ranga Reddy Dist, Hyderabad - 500 078