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The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
Cardiac Rhythm and Heart Failure offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. This role will be supporting our Mechanical Circulatory Support Devices (MSC).
Systems Engineering is a discipline that integrates a variety of technical, scientific and clinical subjects to assess, design and implement efficient and effective solutions. Responsibilities span from the presentation of our devices to patients and clinicians, to requirements definition and architectural design for future/ updated systems, to implementation verification and validation in preparation for commercial release and human utilization.
As a Principal Systems Engineer, you will lead with quality in all actions; Responsible for architecture of new and support of current electronic sub-systems or mechanical sub-systems as well as integration into the larger Ventricular Assist System. Develop and apply engineering theories, methods and research techniques in the investigation and solution of technical problems that are difficult and sometimes undefined. With technical leadership and mentorship of others, including engineers from other functions, perform system engineering work of various complexities with demonstrated technical mastery, especially in electromechanical devices. Lead various system engineering facets of developing new products and sustaining current products. Works on problems of broad scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Represents organization as a primary contact for specific projects. Builds productive internal/external working relationships. Often serves as the mediator and facilitator of complex design choices.
A Day in the Life
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Manages, in some cases as the technical leader/chief architect, major/moderate complex projects, involving delegation of work and review of work products.
Designs and coordinates Class III implantable or external VAD system development project and/or corresponding testing asset including defining complex system requirements, conducting system requirement analysis and hierarchical decomposition, and determining system/sub-system specifications, processes and working parameters.
Exploration of design problems and application of new concepts and approaches to the design and development of new or improved products.
Develops documentation associated with design activities. Author system level documents and represent engineering group in regulatory agency audit and product submission.
Conducts system hazard analysis, risk evaluation, and FMEA (failure mode and effect analysis)
Preparation and review of design input, design verification and risk management documentation.
Initiates, implements solutions and/or resolves system engineering issues such as device hardware/firmware or device/monitor system architecture design tradeoffs, tolerance/performance analysis, etc.
Assists with Heartware VAD system usability assessments.
Maintains traceability between system requirements, sub-system requirements, and their corresponding testing activities.
Performs device/system level activities with little to no supervision
Represents a certain development effort in interdisciplinary discussions, work with technical leaders of different subsystems and/or functional departments to develop optimal system function petition and interface.
Participates and often leads in the scheduling and budget of systems resources and deliverables for their project
Creates innovative solutions that provide HRWT a competitive advantage
Complies with all design-related standards developed by external regulatory groups.
Complies with department and corporate quality initiatives.
BS degree in Software, Electrical or Biomedical Engineering
Experience with class III medical device industry or other critical, regulated industries
Experience with electromechanical devices
7+ years of experience in system engineering design or verification
Nice to Have/ Preferred skills
Master degree in Software, Electrical or Biomedical Engineering
10+ years in system engineering design
Strong working knowledge of FDA regulation requirements on Class III medical device system and required traceability practices
Strong working knowledge of system specification development and maintenance
Strong working knowledge of system level design trade-off/constraint
Solid understanding of systems engineering principles; advantages and limitations of different systems engineering tools and systems quality control principles and their application
Experience with Six Sigma or Design for Reliability and Manufacturing practices
Applied software or bench models to predict the capability of design features or device behaviors to meet specifications
Strong working knowledge of electromechanical systems
Proficient knowledge of FDA regulation requirements on Class III medical device system and required traceability practices
Proficient knowledge of system specification development and maintenance
Proficient knowledge of system level design trade-off/constraint
Broad knowledge of project management
Strong working knowledge of hazard analysis, risk evaluation, and FMEA techniques
Working familiarity with state-of-the-art system development methodology and tools
Proven technical leadership skills
Excellent teamwork and interpersonal skills
Excellent analytical and problem solving skills
Excellent writing, reading, speaking, and listening skills
Ability to give and receive instructions
Good long- and short-term memory
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
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 Day in the Life 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.