
Systems Engineer
- Burnsville, MN
- $50.00-67.00 per hour
- Permanent
- Full-time
- Responsible for creating and building internal requirement sets and assisting the customer in developing user requirements, when needed.
- Support developing the risk management plan and report.
- Assist in creation, review, and documentation of risk analyses.
- May assist development of a Hazard Analysis.
- Accountable for ensuring product verification and validation and ensuring traceability is met for all requirements.
- Coordinate and facilitate interdisciplinary technical discussions within project teams.
- Responsible for coordinating and documenting system level analysis including system modeling, algorithm development, simulations, and system architecture.
- Serve as the primary technical contact for customers on projects.
- Accountable for the technical project scope and effort.
- Participate in the efforts to identify and implement technology re-use.
- Perform and participate in technical design reviews during product realization.
- Assist in evaluating technical talent.
- Identify technical training and tools for the systems engineering team.
- Bachelor's degree in Computer Science or an Engineering discipline.
- Master’s Degree in Engineering is a plus.
- Five or more years of experience, preferable in the medical device field, in the discipline of systems engineering.
- Experience with system designs compliant with IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304 standards.
- Experience with requirements management tools is a plus.
- Experience with modeling tools (Matlab, Simulink, etc.) is a plus.
- Knowledge of FDA 510(k), PMA, and De Novo pre-market submission processes is a plus.
- Experience developing Class II and III medical devices is a plus.
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)