Systems Engineer - Senior

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Help bring the next generation of life-changing medical technology to patients worldwide.

Medtronic's Coronary and Renal Denervation (CRDN) business is looking for a Senior Systems 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.

This is an on-site position based in Mounds View, MN. #CRDNR&DEng

A Day in the Life

This Senior Systems Engineer 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:

• Support organizing and leading system level testing

• Define test tool needs, equipment requirements and specifications

• Define iterative test integration strategy and protocols

• Develop test methods

• Use critical thinking skills and technical knowledge to solve complex systems interaction problems in the fields of coronary artery disease or renal denervation.

• Provide expertise in multiple roles in the product development life cycle through deep knowledge of system functionality.

• Work closely with cross-functional partners such as R&D Engineering, Quality, Manufacturing, Regulatory, and Marketing to take a product from ideation to market release. Advise the project management team, with ability to clearly communicate to project management regarding key product risk / benefit trade-offs.

• Lead cross-functional teams to make appropriate, timely decisions and recommendations that result in the successful completion of major project objectives.

• Execute multiple systems engineering activities in the product development life cycle including identification, planning, monitoring, and executing tasks for entire project

• Collaborate with internal and external stakeholders to develop Business and Customer Needs for new product development

• Design or support development of a systems architecture that aligns product development with the needs of the business and the customer

• Contribute to defining new technologies through the understanding and utilization of knowledge in implant design and in-vivo use conditions

• Support or lead key design trade-offs for assigned features. Present to project management, and drive decisions. Extensive ability to foresee problems and provide alternate solutions.

• Create or support development of a program risk burn down profile and system integration strategy

• Apply knowledge of biomedical / systems engineering principles, systems engineering competencies, and systems engineering methodologies.

• Support or represent the Systems Engineering organization as the prime technical contact on projects and systems engineering initiatives for assigned features, tools, or subject matters. Interacts with senior Medtronic and external personnel on significant technical matters often requiring coordination between projects.

• Provide input supporting submissions to and audits for regulatory bodies and governmental agencies.

• Define interface requirements between systems for assigned features (e.g. software, firmware, hardware, mechanical)

• Responsible for completeness and correctness of requirements

• Maintain traceability of requirements documentation

• Ensure product lifecycle is understood and included in design requirements

• Manage changes to interfaces for assigned features during development and throughout full product lifecycle

• Manages configuration compatibility through product lifecycle

• May be involved in product preclinical trials to investigate specific life science questions within field of expertise.

• Works 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.

Must Have: Minimum Requirements

• Bachelors degree required

• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have:

• BS or MS in an Engineering discipline

• Understanding, defining, and designing to use cases

• Extensive catheterization lab experience

• Experience with requirement management/ A&PLM tools

• Biomedical sensors, software development, wireless communications

• Ethnographic research

• Usability testing

• Understanding and experience in design, development, and testing of embedded, electro-mechanical medical devices

• Understanding and experience with developing Test Methods and Test Equipment

• Experience with general electronic bench test equipment: oscilloscopes, DMM's, Data Acquisition devices

• Experience with IEC 60601-1

• Familiarity with Model Based Systems Engineering

• Experience with Minitab, Python, R, or Power BI for statistics and data analysis

• Experience with capital equipment

• Experience with wireless communication protocols

• Experience with cyber security

• Experience with product concept development, customer interaction, systems engineering, verification of engineering requirements, and validation of customer needs/design requirements

• Working knowledge of systems engineering principles, requirements management, and medical device regulation

• Demonstrated strength in written and verbal communication, judgment, decision making, and critical thinking

• Demonstrated strength in building strong relationships at all levels of the organization, cross-functionally, and with key people external to the organization

• Practical knowledge of project management.

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)

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

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. Learn more about our benefits here.

Medtronic Incentive Plan: This position is eligible for an annual Bonus Program. Learn more about Medtronic Incentive Plan (MIP) here.