Systems Engineer – Medical Devices

Job Title: Systems Engineer Medical Devices
Location: Plymouth, MN - Fully Onsite
Employment Type: Contract (W2)
Duration: 12 Months

Job Responsibilities

• Support systems engineering activities from new product development through product lifecycle management.
• Translate clinical and user needs into system requirements and maintain requirements traceability.
• Develop design concepts and system architecture; support system integration, verification, and validation (V&V).
• Maintain Design History Files (DHF) and product risk-management documentation.
• Assess the impact of design, material, process, manufacturing, and field changes.
• Identify technical risks, troubleshoot system issues, and develop mitigation strategies.
• Collaborate with Software, Electrical, Mechanical, Quality, Regulatory, Manufacturing, and Service teams.
• Ensure compliance with applicable FDA, ISO, IEC, and design control requirements.

Required Qualifications

• Bachelor's or master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or a related field.
• At least 3 years of relevant engineering experience.
• Strong systems engineering experience involving electromechanical and software systems.
• Experience developing medical devices or other highly regulated products, including aerospace, automotive, or military systems.
• Hands-on experience with requirements management, risk management, system integration, and V&V.
• Experience with DHF documentation and design controls.
• Knowledge of SysML/UML and requirements management tools.
• Strong analytical, troubleshooting, communication, and stakeholder-management skills.
• Ability to manage multiple projects and priorities independently.
• Must be local to the Plymouth, MN area and available to work fully onsite.

Preferred Qualifications

• Medical device experience involving ICU, renal care, Continuous Renal Replacement Therapy (CRRT), or acute therapies.
• Experience with connected or software-enabled devices and cybersecurity.
• Familiarity with DOORS, Jama, Teamcenter, TrackWise 8, JIRA, or ALM.
• Experience with Design of Experiments (DOE), statistical methods, and verification testing.

Pay Scale

Anticipated hourly pay rate: $35/hr-$39/hr on W2.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.