Senior Design Assurance Engineer - Pre-Market Quality

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Careers That Change Lives In this exciting role as a Senior Design Quality Engineer Process Development in the Pre-Market Hardware Quality organization, you will serve as a subject matter expert by leading and providing process development quality support for the new product development programs ranging across electromechanical device manufacturing and sensor fabrication processes. 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 hardware/system work products to ensure compliance. This individual will ensure that all system-level project / program work products as it pertains to risk management and process development / validations (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronics quality, reliability, and compliance requirements. The ideal candidate has a strong background in process design, development and qualification including Test Method Validation (TMV) and design transfer. This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R). This position will work across the organization driving and collaborating with functions in Design & Development, Operations, Quality and Regulatory to assure the successful execution of business goals. DIABETES The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. Were committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease. Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio. A Day in the Life Drive risk management deliverables by facilitating and generating process failure modes effects analysis (PFMEA) and Hazard Analysis and experienced in facilitation / execution of the process FMEAs Lead process development activities for large and complex medical device product development programs by effective utilization of PFMEA structure to identify key process inputs, outputs, control as well noise factors Collaborate with product and process development teams to develop P-diagram/ Input-Process- Output (IPO) matrices, process characterizations, test methods and process validation strategies (IQs/OQs/PQs and TMVs) for new products in development Ensure essential design outputs / critical to quality (CTQ) attributes are traced down to manufacturing process output specifications and controlled in manufacturing processes by partnering with appropriate design and operations team members in early design and development Generate master validation plans/reports and design transfer activities as applicable Play a hands-on role in design transfer planning and ensure development projects are transitioned to manufacturing facilities play a key role if defining success KPIs, design specifications to process output specification flow down, manufacturing process development & qualification for transitioning development projects to manufacturing across multiple Medtronic sites and quality systems. Travel to vendor locations and manufacturing sites as needed to help ensure programs meeting deadlines and troubleshoot issues. Apply methodologies such as Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA) and Cell Operating System (COS) during process design and development phase Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, GR&R etc., to inform decision design decision making and conclusions for deliverables like test method validations, process characterizations and verification, process validation and reliability demonstration activities Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities. Understands the interdependencies of FDA design controls and production and process controls and ensure processes are developed with the right level of control and maturity to deliver products for design verification testing and design validation studies Design Verification/Validation and Reliability demonstration Understands and applies basic Design Verification/Validation methods & principles for developing design verification, validation, and reliability test strategies. Participates and collaborates with test engineers in the development, modification and design review of Protocols, Data Summaries & Record Collaborate with the various product development teams like R&D, Ops, Design / Supplier quality, risk management etc. to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards and regulations Participates on project teams and technical review boards and leads change control evaluations. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products. Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different operating unit (OU) strategies and products. Leading CAPA projects and assisting post market analysis. Participating in support of external and internal regulatory audits and inspections. Driving operating procedures / process improvement activities. Performs other related duties as assigned. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelors Degree in Engineering or Science with 4 years of work experience in Quality and/or Development OR Masters Degree in Engineering or Science with 2 years of work experience in Quality and/or Development. Nice to Have Experience working in a regulated industry (e.g., FDA-regulated). Masters Degree in Engineering, Quality, Regulatory, or related. ASQ-CQE, CSSGB, CSSBB or equivalent certifications Hands on experience in process development for electromechanical devices, sensor fabrication Strong understanding and hands on experience with the FDA production and process controls (P&PC), experience in planning of process validation / test method validation activities Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, GHTF guidance on process validations Formal training in Six Sigma or DRM Greenbelt or Blackbelt Ability to author technical reports, business correspondence and standard operating procedures. Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements. Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization. Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable. Self-Starter with a sharp focus on quality and customer experience. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$94,400.00 - $141,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_namesignon&co_num30601&co_affidmedtronic) About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000 passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) . It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. At Medtronic, most positions are posted on our career site for 3-7 days. Welcome to our new Careers Site If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000 passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thats who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world . Here, its about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHRmedtronic.com To request removal of your personal information from our systems please email RS.HRCompliancemedtronic.com