Job Directory Systems Engineer II

Systems Engineer II
Framingham, MA

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Job Description

Systems Engineer II

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 Systems Engineer, you will demonstrate quality in all actions; Responsible for development of new and support of current electronic sub-systems or mechanical sub-system of Ventricular Assist Systems. Develop and apply engineering theories, methods and research techniques in the investigation and solution of technical problems. With general supervision, perform system engineering work with technical competence. Participate in various system engineering facets of developing new products and sustaining current products. Works on problems of narrow scope where analysis of situations or data requires a focused view of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal working relationships.

A Day in the Life

* Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
* Typically aiding more senior systems engineers with contributions and support towards Class III implantable or external VAD system development project and/or corresponding testing asset including helping define 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. Contributes to system level documents.
* Conducts system hazard analysis, risk evaluation, and FMEA (failure mode and effect analysis) along side quality and clinical engineers
* Preparation and review of design input, design verification and risk management documentation.
* Contributes toward resolution of 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 general 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.
* 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 or another degree with applicable experience
* 2+ years of experience in system engineering design or verification
* 0 years of experience with an advanced degree

Nice to Have/ Preferred skills

* 4+ years in system engineering design preferred
* Experience with class III medical device industry or other critical, regulated industries
* Master degree in Software, Electrical or Biomedical Engineering
* Exposure to system specification development and maintenance
* Exposure system level design trade-off/constraints
* Exposure to FDA regulation requirements on Class III medical device system and required traceability practices
* Exposure to hazard analysis, risk evaluation, and FMEA techniques
* Some familiarity with state-of-the-art system development methodology and tools
* Strong understanding of systems engineering principles; advantages and limitations of different systems engineering tools and systems quality control principles and their application
* Demonstrated technical abilities in classroom or internships
* Strong teamwork and interpersonal skills
* Strong 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.

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