Senior Software Quality Engineer
Location: US, CO, Denver
Department: Surgical Technologies
Employment type: Full-time
Required experience: Mid-Senior level
Required education: Bachelor's Degree
Industry: Medical Devices
Function: Engineering
Company profile: The team at Top Source Talent is known within the technical industry for delivering excellent service with qualified resource placements to meet our client’s needs in this ever changing employment market. With our industry expertise and network coupled with our passion for service we look forward to exceeding your recruitment expectations.
Description: Our client is a leading manufacturing company of medical devices is looking for people who want to make meaningful contributions to the world's leading medical technology company. They are seeking a Sr. Software Quality Engineer in Louisville, CO.Position Description Works with minimal guidance to support the design, development, test, and market release of software used in both surgical navigation applications and other medical devices. Contribute to the processes and tools used to create and test software applications. Develop and assess the quality programs and systems of Medtronic Navigation to applicable standards.Position Responsibilities • Actively participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.• Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques.• Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System in regards to software and system design.• Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release.• Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures.• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.• Provide QA oversight to assigned suppliers. Disposition nonconforming product at the Material Review Board meetings. Interface as necessary with suppliers to ensure product specifications are met. Lead supplier audits and assessments. • Promote continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen.• Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
Requirements: Basic Qualifications EDUCATION REQUIRED• B.S./B.A. in Engineering or similar related fieldYEARS OF EXPERIENCE • 5+ years of previous experience in an engineering position with B.S./B.A.• 3+ years of previous experience in an engineering position with M.S./M.A.• 0+ years of previous experience in an engineering position with Ph.DDesired/Preferred Qualifications • Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards.• Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle.• Some knowledge in one or more of the following areas: C/C++, Linux/Unix, Java, External Communication (RS-232, TCP/IP, wireless)• Formal training in Lean and Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable.
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