Sr Principal Systems Engineer (CRDN), Mounds View, MN

Medtronic•Mounds View, MN

7h•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Careers That Change Lives Medtronic’s Coronary and Renal Denervation (CRDN) business is looking for a motivated engineer to be part of a high-performing team that is revolutionizing the design and development of medical devices. In this role, you will leverage both your technical breadth and business acumen to accelerate the design and development of next generation medical devices. The work you do will impact patients globally and help support Medtronic’s mission of alleviating pain, restoring health, and extending life for millions. This engineering position requires strong technical and leadership skills to support the design and development of innovative, new products within the Cardiac and Vascular Group. The Senior Systems Engineer will apply knowledge of systems engineering and experience in working on complex multidisciplinary problems and will provide leadership of projects from early phase development to market release. The ideal candidate will have a passion for the patients we serve and an unrelenting desire to improve our business. The candidate will be motivated and must have exceptional soft skills that will be used to work with a team. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. This position will be based in Mounds View, MN A Day in the Life We are a learning culture, an inventive and collaborative group. We are dedicated to making sure that every patient gets the best product —when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare. The candidate will be responsible for completing system engineering activities with the goal to define, verify, and validate CRDN systems through the integration of sub-systems, features, and technologies. These activities include a) identification of customer needs, b) system definition by translating customer needs into engineering requirements, c) system architecture, partitioning, and development, d) technical risk management activities, e) system verification and validation, and f) system support and education. Systems Engineering activities typically involve trade-offs between risks, benefits, and performance. Systems Engineering activities are performed within the constraints of a complex regulatory environment, in partnership with development (software, firmware, hardware, mechanical engineering), research, clinical, regulatory, product planning, and marketing groups. A key focus of this role will be to support development, characterization and integration testing for a next generation Renal Denervation RF ablation generator. Tasks include: Integration and Verification Testing: Perform system testing activities and coordinate testing efforts with other team members Define iterative test integration strategy and protocols Write and develop test cases & test methods, ensuring comprehensive test coverage Perform functional and characterization testing Develop, review, and execute test plans and test cases based on new requirements for various system components Test Equipment & Test Method Development: Define test tool needs, equipment requirements and specifications Perform system testing activities and coordinate testing efforts with other team members Define and analyze use cases and use conditions to develop test concepts and methods Systems Engineering: Responsible for needs, requirement & architecture definition, allocation / decomposition, and traceability Define interface requirements between systems (e.g. sw, hw, firmware, mechanical) Manage requirements, interfaces, and configuration compatibility through product lifecycle Use critical thinking skills and technical knowledge to solve complex systems interaction problems in the fields of coronary artery disease or renal denervation Organize, lead, and present assigned design trade-offs and drive decisions Assist in the development of a program risk burn down profile and system integration strategy Organize and lead system level Verification and Validation Activities Support submissions and audits for regulatory bodies and governmental agencies May be involved in: Product preclinical trials to investigate specific life science questions Represent the Systems Engineering organization as the prime technical contact on projects and systems engineering initiatives Interacting with senior Medtronic or external personnel on significant technical matters often requiring coordination between projects Work independently under limited supervision to determine and develop approach to solutions. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies – from design to implementation – while adhering to policies, using specialized knowledge and skills. Perform other job-related duties or special projects as required

Requirements

Bachelors degree in Engineering, Physics, or a related degree program required.
Minimum of 10 years of relevant experience OR Master's degree with a minimum of 8 years relevant experience OR PhD with 6 years relevant experience.

Nice To Haves

Understanding and experience in design, development, and testing of embedded, electro-mechanical medical devices
Understanding of and experience with developing Requirements, Test Methods and Test Equipment for embedded medical devices
Electronic bench test equipment: oscilloscopes, DMM’s, Data Acquisition devices
Defining use cases & test cases and Python based test scripts
Using Minitab, Matlab, Python, or R for statistics and data analysis
Developing and executing system-level validation protocols and reports
Experience with requirement management/ A&PLM tools
Electrical safety testing and electrical safety standards (60601-1)
Usability testing
Experience with Design for Six Sigma or related product development processes
Basic knowledge of software development and computer programming
Working knowledge of systems engineering principles, requirements management, project management, and medical device regulation
Demonstrated ability to build strong relationships at all levels of the organization, cross-functionally, and with key people external to the organization

Responsibilities

Perform system testing activities and coordinate testing efforts with other team members
Define iterative test integration strategy and protocols
Write and develop test cases & test methods, ensuring comprehensive test coverage
Perform functional and characterization testing
Develop, review, and execute test plans and test cases based on new requirements for various system components
Define test tool needs, equipment requirements and specifications
Define and analyze use cases and use conditions to develop test concepts and methods
Responsible for needs, requirement & architecture definition, allocation / decomposition, and traceability
Define interface requirements between systems (e.g. sw, hw, firmware, mechanical)
Manage requirements, interfaces, and configuration compatibility through product lifecycle
Use critical thinking skills and technical knowledge to solve complex systems interaction problems in the fields of coronary artery disease or renal denervation
Organize, lead, and present assigned design trade-offs and drive decisions
Assist in the development of a program risk burn down profile and system integration strategy
Organize and lead system level Verification and Validation Activities
Support submissions and audits for regulatory bodies and governmental agencies
May be involved in: Product preclinical trials to investigate specific life science questions
Represent the Systems Engineering organization as the prime technical contact on projects and systems engineering initiatives
Interacting with senior Medtronic or external personnel on significant technical matters often requiring coordination between projects
Work independently under limited supervision to determine and develop approach to solutions.
May act as a mentor to colleagues or may direct the work of other lower-level professionals.
The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies – from design to implementation – while adhering to policies, using specialized knowledge and skills.
Perform other job-related duties or special projects as required

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)