Principal Systems Engineer
Company: Medtronic GmbH
Posted on: November 19, 2021
Careers that Change Lives
You'll always have new challenges pursuing ideas that are exciting,
innovative, and just plain cool. Build out the future of robotic
healthcare. Think critically about healthcare problems and/or
opportunities to advance science faster than others. Do research on
improving the healthcare of millions.
A Day in the Life
The Systems Engineer will be a member of the R&D engineering
team working in the development and support of MITG respiratory and
patient monitoring products. Systems Engineers are expected to work
with other cross-functional members of the engineering staff to
provide technical systems level expertise and solutions to
engineering problems. The Systems Engineer will work with various
department function leads and project engineers in establishing
high level product requirements and systems architecture, and will
collaborate with the various engineering disciplines in creating
mechanical and electrical hardware designs, firmware designs,
project schedules, test plans, and other project documentation from
the concept phase through successful product launch.
Responsibilities may include the following and other duties may be
- Leads stakeholders' needs gathering process. Translates voices
- Participates as a member of systems project or sub-project
team(s) in developing product systems architectures. May act as
technical lead on assigned programs.
- Works with program core team members including Quality and
Regulatory to ensure--conformance to established design development
processes and procedures.
- Works with the various engineering disciplines to translate
market-driven requirements into technical specifications, and
ultimately flow them down into lower level hardware, software and
firmware requirements documents.
- Leads the requirements development, systems level architecture
design and external communications/connectivity interface designs
by collaborating with cross-functional disciplines within and
- Works with program managers to create and manage project
schedules. Leads and facilitates architectural and design decisions
to ensure on-time delivery of projects. Escalates resource and
technical issues in a timely fashion to R&D leadership.
- Responsible for ensuring 100% requirement to
Verification/Validation--test plan coverage on programs.
- Leads FMEA discussions at all levels to ensure product quality
- Leads functional process and tool improvement initiatives by
being early adopter of ideas on projects without impacting project
- Functions well in a team environment. Gains consensus, leads,
influences and ensures cross-discipline participation and
- Demonstrates good design practices and methodologies.
- Performs technical planning, system integration, verification
and validation, evaluates alternatives including cost and risk,
supportability and analyses for total systems.
- Analyses are performed at all levels of total system product to
include: concept, design, fabrication, test, installation,
operation, maintenance and disposal.
- Ensures the logical and systematic conversion of product
requirements into total systems solutions 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. Must Have: Minimum Requirements
- Minimum of 7 years of relevant experience, or advanced degree
with a minimum of 5 years relevant experience Nice to Have
- M.Sc.--/ M.E Biomedical Engineering / Master of System
- 7+ years systems engineering experience in the medical devices
- Experience as a systems engineer leading all phases of
development of a medical device from concept phase, proof of design
testing, development, V&V, certification and launch.
- Medical device design and development
- Familiar with medical devices standards such as 60601-1,
- Familiar with systems engineering processes, establishing
design inputs and top bottom design using system requirements
- Familiar with risk management techniques (i.e. Failure Modes
and Effects Analysis - FMEA).
- Familiarity with and working knowledge of automated
requirements traceability tools, such as Polarion, Doors ,
- Familiar with medical devices design controls.
- Extensive experience in software development and software
architecture. Hardware and firmware development and the processes
associated with product life-cycles, such as stage/phase gate
product development processes.
- Able to work, influence and lead in a highly cross functional
- Familiarity with FDA Quality Systems Regulations (QSR)
- Good communication and interpersonal skills. Able to
collaborate across technical and non-technical disciplines. Good
- Familiar with HL7 and FHIR.
- Understanding of IP networks to practical implementation.
- Familiar with DRM tools such as concept engineering and
requirements flow. 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 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. Contact your manager or local HR to understand the
Work Conditions and Physical requirements that may be specific to
each role. (ADA-United States of America)
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. Learn more about our benefits here .
This position is eligible for a short-term incentive plan. Learn
more about Annual Salary and Medtronic Incentive Plan (MIP) on Page
6 here . It is the policy of Medtronic to provide equal employment
opportunity (EEO) to all persons regardless of age, color, national
origin, citizenship status, physical or mental disability, race,
religion, creed, gender, sex, sexual orientation, gender identity
and/or expression, genetic information, marital status, status with
regard to public assistance, veteran status, or any other
characteristic protected by federal, state or local law. In
addition, Medtronic will provide reasonable accommodations for
qualified individuals with disabilities. This employer participates
in the federal E-Verify program to confirm the identity and
employment authorization of all newly hired employees. For further
information about the E-Verify program, please click here .
Keywords: Medtronic GmbH, Boulder , Principal Systems Engineer, Other , Boulder, Colorado
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