At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all You ll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the Life Software Design Quality engineer to support CST ET products Responsibilities may include the following and other duties may be assigned Review New Product Introduction NPI and Released Product Management Released Products documentation for quality characteristics including manufacturability serviceability testability reliability and product requirements Hands on experience with tools package release process for both Software Hardware tools accessories Review non product off-the shelf tools for products Experience in software or hardware design transfer process for tools or products Familiar with ISO 13485 IEC 62304 ISO 14971 IEC 60601 21 CFR part 820 21 CFR part 11 EUMDR and product specific industry standards Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304 FDA Quality System Regulations EU MDR and inhouse Standards Participate on cross-functional teams to develop product risk management file risk management plan risk assessments DFMEA and risk management report Assist in the creation or review of verification and validation plans protocol and reports Oversee testing and analysis for standards and product requirements compliance Hanson experience in SW anomaly evaluation and disposition complaint investigation NC CAPA Ensure successful transfer of new products tools to production facility by assisting in development of process validation requirements PFMEA IQ OQ PQ using appropriate statistical tools and techniques Review Design History Files and Technical Files for conformance to applicable requirements Participate when appropriate in audits Ensures applicability to SOUP OTS validations in the product development Participate and provide input to training on department procedures and policies Hands-on experience on Software Risk Management Design Controls Develop templates and training based on the quality system regulations applicable standards and guidance Independently reviews all SW deliverables to ensure compliance with development process and the standard Deliver presentations to the QA organization on status and issues of assigned projects Deliver training to departments outside of QA Previous experience working in a cross-functional team environment Provide Quality support to facilitate resolution of product complaints and or safety issues Provide support to the Regulatory Department in writing technical submissions Required Knowledge and Experience B E or B Tech in Software Electrical engineering Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Previous experience working in a cross-functional team environment Familiar with statistical software tools Minitab Stat Graphics Working knowledge of and auditing experience to the FDA Quality System Regulation ISO 13485 and the Medical Device Directive Strong in software design and development software verification and validation activities Computer literate and experience with PCs networks applications software development life cycle Travel may be required Knowledge in cybersecurity Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position Benefits Compensation Medtronic offers a competitive Salary and flexible Perks Package A commitment to our employees lives at the core of our values We recognize their contributions They share in the success they help to create We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage This position is eligible for a short-term incentive called the Medtronic Incentive Plan MIP About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions Our Mission to alleviate pain restore health and extend life unites a global team of 95 000 passionate people We are engineers at heart putting ambitious ideas to work to generate real solutions for real people From the R D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves We have the talent diverse perspectives and guts to engineer the extraordinary

📌 Sr Design Quality Engineer (Telangana)
🏢 Medtronic
📍 Telangana