Quality Engineer III

Job 2710 - Quality Engineer - Contract located near Minneapolis, Minnesota Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.OnsiteAbout The RoleOur Client is currently recruiting for a Senior Design Assurance Engineer in our Minnesota 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 of our Client's.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 VV process. This includes quality plans, risk management plans, reports, hazard analysis product risk management workbook user FMEA and design FMEA, sampling systems / procedures, statistical techniques verification protocols/testing/reports and 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 IncludeSupport remediation assessment teams with the evaluation of risk documentation and post market record review PIR CAPA past Field Actions as applicableLead 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 QualificationsWhat We Are Looking For In You 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 QualificationsExperience with class III medical devicesBS in Electrical EngineeringPrevious RD experienceStrong knowledge of QSR and ISO standardsMedical device experience - ASQ certificationMEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.Sponsorship is not available for this positionCheck us out at www.medicalengineeringconsultants.comAAP/EEO DFWPReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.