Senior 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 Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Capable of mentoring junior quality engineers in providing quality engineering support for their medical device products. 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. Acts as the subject matter expert on risk management for one or more products/platforms. Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab, Stat Graphics) Familiar with ISO 13485, ISO 14971, IEC 60601 and product specific industry standards. Hands-on experience on EU MDR. 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. Review Design History Files and Technical Files for conformance to applicable requirements. Assist in creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance. Participate and provide input to training on department / division procedures and policies. Participate when appropriate in audits Independently develop test strategies for new, pre-concept features in development. Provides guidance to junior quality engineers. Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. 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. Hands-on experience on Risk Management, Design Controls for Medical Devices. Required Knowledge and Experience: B E or B.Tech in Mechanical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-10 years of experience Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab, Stat Graphics) Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills including protocol / report development andtechnical presentations. Fair Knowledge in Risk Management 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 have: ISO 13485 Internal Auditor / Lead Auditor Certification. Experience in Test Method Validation (TMV) including statistical justification and GR&R. Strong understanding of statistical ... (truncated, view full listing at source)