Only 24h Left Senior Design Quality Engineer

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 Sr Design Quality Engineer role for ENT Responsibilities may include the following and other duties may be assigned Review new and modified product design documentation for quality characteristics including manufacturability serviceability testability reliability and product requirements Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations EU MDR and inhouse Standards Participate on cross-functional teams to develop product risk management file risk management plan Hazard Analysis DFMEA and risk management report as per ISO 14971 Familiar with ISO 9001 ISO 13485 ISO 14971 IEC 60601 21 CFR part 820 21 CFR part 11 EUMDR and product specific industry standards Review Design History Files and Technical Files for conformance to applicable requirements Hands-on experience on CAPA support and field complaint analysis Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements PFMEA IQ OQ PQ using appropriate statistical tools and techniques Assist in creation of verification and validation plans protocol and reports Oversee testing and analysis for standards and product requirements compliance Familiar with statistical software tools Minitab Stat Graphics Participate and provide input to training on department division procedures and policies Participate when appropriate in audits Deliver presentations to the QA organization on status and issues of assigned projects Deliver trainings to departments outside of QA Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor subject matter expert leader facilitator Previous experience working in a cross-functional team environment Required Knowledge and Experience B E or B Tech in Mechanical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Previous experience working in a cross-functional team environment Good verbal and written communication skills including protocol report development and technical presentations Comparative Statistical techniques sampling plans GR R K-factor hypothesis testing ANOVA parametric and non-parametric analysis Familiar with DMAIC or DMADV DFSS methodologies 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 Benefits 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 Learn more about our business mission and our commitment to diversity