Systems Engineer

The Fountain Group

The Fountain Group is currently seeking a Systems Engineer for a prominent client of ours. This position is located in St. Paul, MN . Details for the position are as follows:

Job Description:

Location: St. Paul, MN (100% onsite)
Pay: $55 - 58/hr W2
12 months contract, high possibility for extension based on performance and budget.
Shift: 8am to 5pm.
As a Systems Engineer, you will be a critical contributor on our Electrophysiology Systems Engineering team focused on delivering the future in Advanced Mapping technologies.
This role will involve a range of responsibilities, including, but not limited to, collaborating with and leading teams in the development and analysis of system performance and system integration for our next-generation products.
In this role, you will be a key member of Client's product development team to bring systems from concept to launch.

Required Skills:

Systems Engineer with proven experience developing complex, integrated electromechanical/electrical medical-device systems - ideally someone who has led system architecture, requirements, integration, and troubleshooting across hardware + software + signal processing, with cardiac electrophysiology/mapping/ablation experience being the home-run background.
Bachelor's degree with extensive experience with complex product-development engineering experience - electrical, biomedical, or closely related engineering background.
Understand how hardware, software, algorithms/signal processing, clinical requirements, and regulatory requirements come together, and lead a complex medical device from concept through launch.
True Systems Engineering experience - highly important. Ideally 3+ years specifically as a Systems Engineer, owning system-level architecture, behavior, requirements, interfaces, integration, and technical problem solving.
Regulated product development. FDA/ISO design controls and documentation experience are important. IEC 60601 experience highly desired.
Hardware + software + signal-processing systems. This is a major technical requirement. They want someone who's worked on products where electrical hardware, embedded/software functionality, and signal processing/algorithms interact as one system.
Medical device product development - strongly preferred. Experience taking regulated products through concept → requirements/design → integration → verification/validation → launch is significantly better than general systems engineering.

Experience and Education Requirements:

Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related field with 10+ years of experience in developing highly complex electrical hardware, software, and signal-processing based systems.
Demonstrated ability to leverage and/or engage others to accomplish project goals.
Demonstrated ability to solve complex engineering problems and mentor other engineers.
Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to multitask, prioritize, and meet deadlines in a timely manner.
Strong organizational skills, as well as attention to detail.

Preferred Qualifications

Masters degree in Engineering and/or Science (could substitute for 2 years of engineering experience)
3+ years of experience as a Systems Engineer
Medical device experience, specifically supporting cardiac mapping and/or ablation systems
Experience working in a broader enterprise/cross-division business unit model
Detailed understanding of 60601 and other related electrical hardware regulations.
Experience in managing one or more direct reports

Duties and Responsibilities:

Contribute to the technical and business strategy at the core team level for major system-level programs with a good understanding of the software development lifecycle.
Utilize multidisciplinary engineering knowledge and experience to design, develop, and troubleshoot new products specific to cardiac mapping and ablation.
Provide system engineering leadership and take ownership for overall project success for new products from concept phase through launch.
Work with Product Marketing, Clinical Engineering, and Key Opinion Leaders to develop design input requirements from user and business needs.
Communicate to Sr. Management, including technical presentations, status updates, and program reviews.
Lead project-level system architecture and system behavior definition activities utilizing use case modeling and other appropriate tools. Help define systems and product requirements.
Lead cross-functional working groups to solve complex problems, mitigate risks, and develop strategies to overcome challenges.
Plan, manage, and report on overall systems integration activities, including root cause analysis and solution generation.
Provide input into the technology and product roadmaps.
Be a strong team player and lead cross-functional teams to resolve issues and meet budget and schedule requirements.
Create a positive, collaborative culture amongst the technical teams while working to solve challenging engineering problems.
Mentor junior engineers.
Ensure compliance with procedural and documentation requirements of Client, FDA, ISO, and other regulatory bodies.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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Vacancy posted 3 days ago

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