Systems Engineer

About the role

This position is located in St. Paul, MN (100% onsite). The role is a 12-month contract with high possibility for extension based on performance and budget. The shift is 8am to 5pm.

Responsibilities

• Contribute to 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.

Requirements

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field.
• 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.

Qualifications

• Systems Engineer with proven experience developing complex, integrated electromechanical/electrical medical-device systems.
• Led system architecture, requirements, integration, and troubleshooting across hardware + software + signal processing.
• Cardiac electrophysiology/mapping/ablation experience is preferred.
• True Systems Engineering experience — highly important.
• 3+ years specifically as a Systems Engineer, owning system-level architecture, behavior, requirements, interfaces, integration, and technical problem solving.
• Regulated product development experience, including FDA/ISO design controls and documentation.
• IEC 60601 experience highly desired.
• Experience with hardware + software + signal-processing systems where electrical hardware, embedded/software functionality, and signal processing/algorithms interact as one system.
• Experience taking regulated products through concept → requirements/design → integration → verification/validation → launch.

Preferred Qualifications

• Master’s 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 IEC 60601 and other related electrical hardware regulations.
• Experience in managing one or more direct reports.

Pay

$55 – $58/hr W2 for the 12-month contract.