Principal Systems Engineer
Framingham, MA

Job Description

Principal Systems Engineer

Careers that Change Lives

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

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.

Basic Qualifications

* 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

About Medtronic

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.