Senior Engineer, Systems Engineering

The Senior Systems Engineer leads the translation of customer needs into engineering requirements, driving system architecture and design across hardware, software, and algorithm subsystems. The role ensures requirements are complete, traceable, and aligned with product performance, safety, and regulatory standards, while leading system verification and validation and maintaining end-to-end traceability from user needs through V&V.

The Senior Systems Engineer requires deep expertise in regulated medical device development (IEC 62304) and serves as the primary cybersecurity engineering resource, with hands-on experience in threat modeling, vulnerability assessment, and post-market cybersecurity management. Cross-functional collaboration across engineering disciplines, geographies, and cultures is essential.

Hybrid from Woodbury, MN

• Leads system requirements and architecture development across hardware, software, and algorithm subsystems, ensuring system performance, maintainability, and end-to-end traceability from user needs through verification.
• Owns the planning, execution, and documentation of system verification and validation testing to ensure the product meets customer needs and regulatory requirements, including IEC 62304compliance.
• Drives the risk management process, leads risk analysis activities, and develops verification testcases to demonstrate risk mitigation effectiveness.
• Serves as the primary cybersecurity engineering resource within the Systems Engineering team, leading threat modeling, vulnerability assessment, and the development and integration of cybersecurity requirements and test cases in collaboration with cross-functional teams, ensuring compliance with customer needs and applicable standards (e.g., FDA guidance, IEC 81001-5-1).
• Leads and supports post-market cybersecurity activities in coordination with technical operations, software engineering, and other cross-functional teams, including vulnerability monitoring, risk evaluation, and timely remediation.
• Drives effective communication across geographies and functional teams to align on requirements, test protocols, and reports.
• Leads root cause analysis of system nonconformance and drives timely resolution.
• Mentors and provides technical guidance to junior and mid-level Systems Engineers.

• Conducts informal and exploratory testing of released software to identify potential defects and provide early feedback on product quality.
• Leads technical research to support system design decisions and root cause investigation of identified defects.
• Works with the Technical Operations group to set up the test, pilot, and commercial instances.
• Champions process improvement initiatives for the product development lifecycle.
• Reviews and provides system-level input on failure mode analyses and related quality documentation submitted by subsystem teams.
• Supports customer sales demos and pilots.

• Bachelor’s in Computer Science, Systems Engineering, Biomedical Engineering, or relevant field.
• 7 years of relevant work experience in systems engineering, system testing, or product development (5 years with a Master's degree).
• Experience developing medical devices under IEC 62304 (software lifecycle processes).
• Extensive experience with system-level requirements development and management.
• Ability to lead cross-functional meetings and coordinate across engineering disciplines.
• Extensive experience in system or subsystem level testing and test process development; proven track record of authoring and reviewing test plans, protocols, and reports.
• Strong understanding of network communications technology (e.g., Wi-Fi, BT, Internet, TCP/IP, Ethernet)
• Expertise in cybersecurity engineering, including hands-on experience with threat modeling methodologies (e.g., STRIDE), vulnerability assessment, and post-market cybersecurity management.
• Oral and written communication skills with the ability to influence technical direction as well as collaborate effectively across diverse, cultural backgrounds.

• 10 years of related systems engineering or product development experience.
• Experience working under additional medical device regulations (e.g., ISO 13485, ISO 14971,QSR) beyond IEC 62304.
• Experience working on human factors engineering standards (e.g., IEC 62366-1).
• Experience in implementing system design using UML diagrams and other diagramming tools.
• Hands-on experience with continuous integration and automated testing pipelines.
• Experience building and managing cloud servers on AWS (e.g., EC2, VPC, security groups).
• Experience with Linux-based operating systems (e.g., Ubuntu), including proficiency with basic Bash commands and shell scripting.
• Experience using Docker for containerized application deployment and management.
• Proven experience working and leading in multi-cultural environments.

• Occasional domestic and international travel.
• Willingness to travel internationally to India, Japan, and Europe.

  Minimum Salary: $97,894.00

  Maximum Salary: $131,055.00

  We consider various factors in determining actual pay including your skills, qualifications, and experience. In addition to salary, this position is eligible for incentive awards based on individual and business performance as well as competitive benefits.

• Comprehensive benefits package including medical, dental, and vision insurance.
• Generous Paid Time Off including paid holidays and floating holidays.
• 401(k) employer match on retirement planning.
• Hybrid working schedule for eligible positions.
• Tuition reimbursement on approved programs.
• Flexible and health spending accounts.
• Talent Development program.