Quality Engineer

Job Title: Design Quality Assurance Engineer Location: Maple Grove, MN 55369 (Arbor Lakes, MN)Duration: 12 Months Contract with Possible of extensionJob Description:One of Medical devices Manufacturing company is currently recruiting for a Senior Design Assurance Engineer in our Arbor Lakes, MN location.This is an exciting opportunity to participate in the assessment, remediation, and sustaining of medical electrical equipment/systems (MEE) within Vascular Therapies (VT), which is a rapidly growing division.The Sr Design Assurance Engineer provides focused quality engineering leadership on sustaining design assurance activities. Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process.This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports.This role will be responsible for supporting risk document and post market record review during remediation activities as well as ensuring quality and compliance through post commercialization sustaining activities.Your responsibilities will include:Support remediation assessment teams with the evaluation of risk documentation and post market record review (PIR, CAPA, past Field Actions (as applicable)Lead or mentors the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification, Reliability and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIREffectively communicates within project team, across functions, and elevates issues above the project team as appropriateDevelops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factorsInfluences cross-functional plans, guides overall project strategy, knows when to solicit feedback, and facilitate project decisionsBuilds quality into all aspects of work by maintaining compliance to all quality requirements, defending work of their team, as well as supports internal external regulatory auditsSupports functional and divisional design quality goals and prioritiesRequired qualifications:Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline5+ years of related experience in design assurance, new product development, or related medical device or regulated industry experienceUnderstanding of electrical safety standards IEC 60601Experience with reliability testingDemonstrated use of Quality tools/methodologiesStrong written/verbal communication skills.Risk documentation per ISO14971Preferred qualifications:Experience with class III medical devicesBS in Electrical EngineeringPrevious R&D experienceStrong knowledge of QSR and ISO standardsMedical device experienceASQ certification