Medtronic Principal Systems Engineer in Boulder, Colorado
Principal Systems Engineer
Boulder, Colorado, United States
Jul 21, 2021
Careers that Change Lives
Youll 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 RD 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 assigned.
Leads stakeholders needs gathering process. Translates voices to needs.
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 ensureconformance 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 outside RD.
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 RD leadership.
Responsible for ensuring 100% requirement to Verification/Validationtest plan coverage on programs.
Leads FMEA discussions at all levels to ensure product quality and reliability.
Leads functional process and tool improvement initiatives by being early adopter of ideas on projects without impacting project schedules.
Functions well in a team environment.Gains consensus, leads, influences and ensures cross-discipline participation and feedback.
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
Bachelors degree required
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 Engineering
7+ years systems engineering experience in the medical devices industry.
Experience as a systems engineer leading all phases of development of a medical device from concept phase, proof of design testing, development, VV, certification and launch.
Medical device design and development
Familiar with medical devices standards such as 60601-1, 60601-8.
Familiar with systems engineering processes, establishing design inputs and top bottom design using system requirements methodologies.
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 , etc.
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 team environment.
Familiarity with FDA Quality Systems Regulations (QSR) preferred.
Good communication and interpersonal skills.Able to collaborate across technical and non-technical disciplines. Good team player.
Familiar with HL7 and FHIR.
Understanding of IP networks to practical implementation.
Familiar with DRM tools such as concept engineering and requirements flow.
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. Lets 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 benefitshere (https://www3.benefitsolver.com/benefits/BenefitSolverView) .
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.