Position Description:
*The Principal Software Quality Engineer will participate in the execution of new product development and sustaining products and administration of quality assurance programs, policies, processes, procedures and controls in compliance with the evolving and complex US and global requirements of the medical device industry.
*The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements including software work products to ensure compliance.
*This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic's quality, reliability, and compliance requirements.
*This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.
Position Responsibilities:
• Review all project / program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
• Collaborate with project / program teams to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
• Plans, develops and implements validation plans for new product development in conjunction with R& D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
• Assists Supplier Quality Assurance with supplier audits; interfaces with Purchasing and Supplier Quality Assurance with supplier issues.
• Generates documentation at the project level including software and system risk assessment, and requirements compliance matrix (ERM).
• Chair cross-functional change control boards (known at Medtronic as Change Review Group (CRG)).
• Assist in the analysis of field returns and in-process non-conformities.
• Perform and lead CAPA projects and activities.
• Provide training, when required, to personnel engaging in design and development, verification and validation, inspection, documentation, and manufacturing.
• Participate in technical design reviews, CCB (Change Control Board) reviews, PQRB (Product Qualification Review Board) reviews, and PAB (Phase Approval Board) reviews.
• Provide guidance and direction to other engineers and technical support staff.
• Drive SOP/DOP updates or creation of new processes based upon upcoming standards or process improvements. Identify and support cost-saving programs and process improvements.
• Apply and improve advanced technical principles, theories, and concepts in the monitoring and coordination of various design, development, testing, and quality activities.
• Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
• Performs other related duties as assigned.
Basic Qualifications:
• Bachelor's Degree in Engineering with 7 years' related experience in engineering and/or quality assurance in a regulated industry (e.g., FDA-regulated, FAA-regulated, DoD, CMMI ML 3+) or Master's Degree in Engineering with 5 years' related experience.
• Working knowledge of embedded systems and application software.
• Working knowledge of various Software Development Life cycle (SDLC) models (e.g. waterfall, spiral / iterative, scrum)
• Working knowledge of risk management (generation of software and system risk analysis), CAPA, and/or Design Controls.
• Experience leading a project.
Desired/ Preferred Qualifications:
• Master's Degree in Engineering.
• ASQ Certification in Quality or Reliability.
• Experience in an electronic manufacturing environment
• Working knowledge of IEC 62304, FDA's General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDD
• Working experience with internationally certified quality systems, USFDA Quality System Regulation, and / or other mature regulatory or process models.
• Strong oral/ written communication skills and interpersonal skills.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining solutions.
• Working knowledge of various medical industry standards.
• Working knowledge of problem solving and statistical methods as applied to process and product quality.
• Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures.
• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
• Ability to represent the department in frequent inter-organizational and outside vendor contacts.
• Experience with embedded medical devices and hardware/firmware.
• Ability to effectively manage multiple system level projects / programs.
• Self-Starter and accountable, with sharp focus on quality and customer experience.
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