Principal Engineer, Systems Engineering

The Principal Engineer, Systems Engineering is a strategic and cross-functional leadership role that drives the execution of complex systems engineering initiatives, manages development cycles, and leads special operations projects across multiple departments. This position requires a deep understanding of product development processes, strong project management capabilities, and the ability to collaborate effectively with cross-disciplinary teams including Product Management, Product Development, Sales, and Marketing. The Principal Engineer, Systems Engineering ensures successful delivery of high-impact projects aligned with organizational goals.

Hybrid from Woodbury, MN

Systems Engineering

• Develop system level requirements from the user needs while managing the cost, the original requirements, and technical constraints.
• Align with the Systems Engineering team to conclude the system level requirements and follow up the design input review and approval processes.
• Clarify the edge cases of the new implementation to support the subsystem requirements and test protocol developments.
• Clarify the subsystem boundaries and coordinate the interface definitions in each component.
• Understand and meet the applicable industry standards (e.g., IEC 60601-1 series, IEC 60601-2 series, ISO 80601-2 series).

Cross-Functional Development

• Coordinate and oversee development in collaboration with Product Management and Product Development teams, specifically in managing cross-functional solutions, development, and V&V execution. Based on the Product Management team defining the problem statement, marketing requirement, or needs from engineering or risk.
• Ensure timely delivery of goals and overall milestones.
• Develop required deliverables for the product commercial readiness phase.
• Manage the product commercial readiness phase and close the product release authorization activities.
• Facilitate communication and collaboration among cross-functional teams to drive project success.

• Lead special projects across sales, marketing, product management, and product development teams.
• Gather and analyze requirements from stakeholders to define project scope and objectives.
• Evaluate potential solutions and develop implementation plans while managing the cost.
• Oversee the execution of projects, ensuring alignment with company goals and timelines.
• Provide regular updates to senior management on project status and outcomes.
• Monitor and report progress, identifying and addressing any roadblocks.
• Conduct risk analysis, developing system level requirements which consider the cost and effectiveness.
• Perform other job-related responsibilities and duties as needed.

• Bachelor's degree in Systems Engineering, Project Management, Biomedical Engineering, or a related technical field.
• 10+ years of experience in systems engineering within a regulated industry, preferably medical devices.
• Demonstrated experience leading cross-functional teams through complex product development cycles.
• Proven track record of managing multiple concurrent projects with competing priorities.
• Strong understanding of systems engineering principles which includes development requirements, interface definition, and risk management.
• Systems-level mindset, proactive, collaborative, and technical rigor with a focus on operational excellence.

• Master's degree in Systems Engineering, Engineering Management, or a related discipline.
• PMP (Project Management Professional) or equivalent certification.
• Project management methodologies such as Agile or Scrum.
• Experience with product lifecycle management (PLM) tools and project management software (e.g., Jira, Confluence, Microsoft Project).
• Knowledgeable with FDA regulations, ISO standards, and design control processes in the medical device industry.

• 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.