Systems Engineer

• Support systems engineering activities across new product development and product lifecycle management.
• Translate clinical and user needs into system requirements and maintain requirements traceability.
• Develop system concepts and architecture, and support system integration, verification, and validation (V&V).
• Maintain Design History Files (DHF) and product risk-management documentation.
• Conduct impact assessments for 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 FDA, ISO, IEC, and medical device design control requirements.

• Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical Engineering, or a related field.
• 3+ years of relevant engineering experience.
• Strong systems engineering background involving electro-mechanical and software-based systems.
• Experience developing medical devices or other highly regulated products, such as aerospace, automotive, or military systems.
• Experience with requirements management, risk management, system integration, and V&V.
• Knowledge of SysML/UML and requirements management tools.
• Strong analytical, problem-solving, communication, and stakeholder-management skills.

• Medical device experience, particularly in ICU, kidney care, CRRT, acute therapies, or connected medical devices.
• Experience with connected/software-enabled devices and cybersecurity.
• Experience with DOORS, Jama, Teamcenter, Track Wise 8, JIRA, or ALM.
• Experience with DOE, statistical methods, and verification testing.
• Ability to manage multiple projects and priorities independently.

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

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.