Careers that Change Lives In this exciting role as a Sr Design Assurance Engineer you will have responsibility for influencing product quality and reliability outcomes across new product development as well as ensuring project compliance to the Quality Management System. The Sr Design Assurance Engineer is a member from the Quality function assigned to a cross-functional product development team for the Targeted Drug Delivery (TDD) business within the Restorative Therapies Group (RTG). The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. Neuromodulation delivers innovative therapies and solutions for neurological diseases, pain, and spasticity Responsibilities may include the following and other duties may be assigned. - Integral member of design team required to participate in activities related to the quality and reliability of the design. - Work closely with Development Engineering to assure appropriate requirement definitions are established. - Participate in design verification and design validation for new products and modifications to existing products. - Assist in the development and implementation of methods and procedures for inspecting, testing, and evaluating products and production equipment. - Be a key contributor in problem solving efforts to identify and resolve challenging quality issues to ensure production of safe and effective medical devices. - Serve as a Design Assurance reviewer/approver on design control documents, specifically those associated with product testing and characterization - Complete reviews and audits of Design History File (DHF) documentation. - Drive functional excellence, lessons-learned, and business and quality management system improvement - Coach and support project team members on compliance with Quality System requirements Must Have: Minimum Requirements - Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality Nice to Have - 2+ years relevant engineering experience with implantable medical products - Masters degree in engineering, science or business - Working knowledge of multiple quality disciplines, especially reliability, safety and compliance - Quality or reliability engineering experience in product development - Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations including FDA 21 CFR Part 820, Part 211, ISO 13485 - Strong working knowledge of quality systems and quality assurance processes and principles, with a focus on development and or verification/validation activities - ASQ Certification in Quality or Reliability. - Strong oral/ written communication skills and interpersonal skills. - Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining solutions. - Self-Starter and accountable, with sharp focus on quality and customer experience. - Technical writing skills About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) Additional Information - Posting Date: Feb 16, 2021 - Travel: Yes, < 25 % of the Time
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