Principal Systems Engineer - NM - Rice Creek, MN (Onsite) - Minnesota Staffing : Job Details

In this role as a Principal Systems Engineer, you will have responsibility for developing new Neuromodulation products from early feasibility through to market release. You will act as an influential systems engineer working within a matrix organization to support the Systems Engineering organization in the definition, design, development, and testing of complex medical device systems within the Neuromodulation Operating Unit. Neuromodulation products provide therapy for a variety of conditions including Chronic Pain, Cancer Pain, Severe Spasticity, Epilepsy, Dystonia, Essential Tremor, and Parkinson's Disease. Products include implantable and external neurostimulators, implantable infusion pumps, and associated device recharge and programming instruments as well as cloud based digital solutions. You will work closely with, and act as a technical leader within, a cross-functional engineering team to synthesize feature needs and technology trends into system requirements and design specifications. Typical system designs involve complex electronic circuits, wireless communication, batteries and a mix of consumer and medical technologies. System are designed with the user in mind to provide innovative solutions in the marketplace. This individual will apply proven communication skills, problem-solving skills, and knowledge of best practices to guide his/her team on issues related to the design, integration and verification testing, operations support, and product release.

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

• Collect and analyze design inputs (customer needs, business needs, etc.) and transform them into high quality engineering requirements.
• Perform system architecture and design for all phases of system development to include: concept, design, fabrication, test, installation, operation, maintenance and disposal.
• Ensure the logical and systematic conversion of system requirements and design into product requirements that acknowledge technical, schedule, and cost constraints.
• Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.
• Lead, coordinate, execute, and document system analysis and design activities including but not limited to architecture definition, interface management, performance modeling, system integration, and design failure modes and effects analyses.
• Develop digital platform solutions including defining, maintaining, and integrating the architecture of data, and data flows, provided by those systems and their users
• Defines the technologies, policies, and data models to be used in collecting, organizing, storing, and accessing information.
• Identify technical development risks, develop and execute risk burn-down plans
• Facilitate cross-functional engineering and project team communication to drive design decisions, align on test and integration strategies, perform hands-on testing, and review test results, identify technical issues and manage their resolution
• Verify system requirements have been properly implemented (writing, leveling, tracing) through inspection, demonstration, test or analysis.
• Validate that implemented systems meet customer needs.
• Support regulatory body submissions and facilitate knowledge transfer to continuation engineering teams.
• Represent the organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
• Manage moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
• Provide guidance, coaching, and training to other employees within job area.
• Establish and advocate for best practices and continuous improvement as to mature the Systems Engineering knowledge and processes.
• Understand and advocate for technology evolution and participate in the development of system and product roadmaps.
• This individual is expected to be a thought leader, proficient in building consensus and establishing strong links between business and engineering, and technology sectors.

Must Have: Minimum Requirements

• Requires a Bachelor's degree in in Biomedical Engineering, Electrical Engineering, Computer Science, Computer Engineering, Mechanical Engineering or similar discipline with minimum of 7 years of experience.
• Or advanced degree with minimum of 5 years of experience.

Nice to Have

• Experience developing system definition, system design and requirements, requirement tracing to subsystems and interface requirements, and system verification and validation strategy and testing.
• Previous medical device experience with a history of developing products from technology to market release.
• Experience with designing for the Hardware/Firmware/communication interfaces of electronic devices.
• Experience in troubleshooting firmware/software interfaces.
• Experience developing sensor-based systems, including closed-loop feedback control systems.
• Experience developing data analytics algorithms, and machine learning algorithms.
• Product Risk Assessment and Risk Management Experience (Fault Tree Analysis, Failure Modes and Effects Analysis, etc.)
• Experience working with and designing systems to meet ISO and Quality System Regulation requirements, including IEC-60601-1, -2, -6, IEC-62304, ISO-14971, FDA 21CFR820.30 for Class I, II and III medical systems.
• Experience planning and providing guidance on architecting automated software and system integration solutions including DevOps CI/CD pipelines and best practices.
• Previous experience establishing and maintaining information systems, IT, cloud infrastructure, health software and firmware designs.
• Demonstrated strong verbal/written communication.
• Demonstrated ability to make decisions quickly and guide a team through complex problems.
• Experience working in cross-functional and team environments.
• Experience working in FDA regulated and/or medical device environment.
• Experience interfacing with physician customers and therapy consultants.

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.

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):$128,000.00 - $192,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans.

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 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.

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. That's 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