Senior Principal Systems Engineer

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.

Responsibilities may include the following and other duties may be assigned.

• This role requires strong technical and leadership skills to support the design and development of innovative, new products within CST R&D .
• The Senior Principal Engineer will apply knowledge of systems engineering and experience in working on complex multidisciplinary problems and will provide leadership for product development from early phase development to market release. 
• The candidate will be responsible for completing system engineering activities for ET products including Navigation & Imaging Systems and also their integration with other OEM products. 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.  

• Use critical thinking skills and technical knowledge to solve complex systems interaction problems
• 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 team, with ability to clearly communicate  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 product objectives.
• Execute multiple systems engineering activities in the product development life cycle including identification, planning, monitoring, and executing tasks for entire product life cycle 
• 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 CST R&D.  
• Support or lead key design trade-offs for assigned features. Extensive ability to foresee problems and provide alternate solutions.
• Create or support development of a program risk burn down profile and system integration strategy
• Support or represent the Systems Engineering organization as the prime technical contact on products 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 products and other groups  
• 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)
• Maintain traceability of requirements documentation and Manage changes to interfaces for assigned features during development and throughout full product lifecycle
• Manages system compatibility through product lifecycle
   

Required Knowledge and Experience:

• Experience in writing end to end System Engineering requirements and accountability for  customer needs alignment.
• Experience with Figma & other wireframe tools and ability to produce flow diagrams along with system requirements.
   Knowledge of  IEC 60601-1
• Familiarity with Model Based Systems Engineering
• Experience with UI design and knowledge of HFE   
• Experience with medical navigation and imaging capital systems
• Knowledge of product 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
• The ideal candidate will possess strong leadership skills and the capability to make trade-offs between risks, benefits, and performance. 
• Principal Working Relationship: Reports to Associate Director
• Experience working with stakeholders from other sites and aligning to changing strategy and business priorities.
• Work with Product Manager/Owner/Marketing for churning System Requirements to align the roadmap with strengths and opportunities
• Strong oral and written communication skills

Nice to Haves

• Experience in MedTech especially Navigation and Imaging Systems
• Familarity with FDA (21CFR 820) & EU MDR Regulation and ISO standards 13485, 62304, 14971

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. 

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.
 

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 95,000+ 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