Systems Engineer

The Fountain Group; Saint Paul (MN); On-site; USD 76,000 - 80,000; Full time

Job summary

The Fountain Group is seeking a Systems Engineer to join our Electrophysiology Systems Engineering team in St. Paul, MN. The role focuses on advanced mapping technologies, leading system-level architecture, requirements, and integration from concept through launch.

Ideal candidates have 10+ years in complex electrical hardware/software/signal-processing systems, with regulated product development experience (FDA/ISO) and cardiac mapping background. Onsite, 100% in St. Paul, MN, contract position.

Qualifications

• Bachelor's degree in Electrical or Biomedical Engineering or related field.
• 10+ years in complex electrical hardware, software and signal processing systems.
• Experience leading system architecture, requirements, integration and troubleshooting.

Responsibilities

• Contribute to system-level programs with an understanding of the software development lifecycle.
• Design, develop, and troubleshoot products for cardiac mapping and ablation.
• Provide system engineering leadership from concept to launch and drive cross-functional teams.

Skills

Systems Engineering

Medical device development

Regulatory compliance

Hardware & software integration

Education

Electrical Engineering degree

Biomedical Engineering degree

Master's degree in Engineering

Job description

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:

• 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.