Sr. Quality Enginr

Job Description

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 Careers that Change Lives Provide Mechanical design quality engineering support in design and development of medical device and non medical products. Facilitate the application of design controls in product development and sustaining changes. Must Have 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. Minimum Qualification 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 Additional Competencies 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 Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt 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. 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 here