Job Title: Senior Systems Engineer – Risk Management
Location: Remote
Employment Type: 6-month contract with potential for extension
Pay: $105-$110
Overview
We are seeking an experienced Systems Engineer to support risk management activities for Baxter’s Front Line Care Patient Monitoring Portfolio. This role requires a strong background in formal systems engineering practices and risk management within a regulated environment. The ideal candidate will act as a subject matter expert, collaborating with cross-functional teams to ensure compliance with ISO 14971 and Baxter’s design control and risk management policies.
Key Responsibilities
- Provide expert guidance to functional owners on planning and updating elements of the risk management file.
- Support end-to-end processes:
- Identify stakeholder needs
- Translate needs into design inputs
- Trace design inputs to design outputs
- Analyze hazardous situations using operational, functional, and physical architectures.
- Drive systems engineering processes to achieve ISO 14971 compliance.
- Communicate effectively with diverse stakeholders, including Quality, Systems/Risk, Project Management, Regulatory Affairs, and Marketing.
- Ensure all work aligns with Baxter’s policies and procedures for design control and risk management.
Qualifications
- Education: Master’s degree in systems engineering
- Experience:
- 10+ years in a formal systems engineering environment.
- Medical device experience, particularly with Quality Management Systems (preferred).
- Certifications: INCOSE Certified (preferred).
- Technical Skills:
- Software development experience (plus).
- Software/Electrical Engineering development experience (plus).
- Strong understanding of risk management principles and ISO 14971 compliance.
- Proven ability to work collaboratively and communicate across multiple functions.
Preferred Attributes
- Ability to manage complex systems and risk management processes.
- Strong analytical and problem-solving skills.
- Familiarity with regulated environments and design control processes.