Senior Systems Engineer – Risk Management
Share
Job Location:
Monthly Salary:
Experience Required:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
This is a remote position.
Job Title: Senior Systems Engineer Risk Management
Location: Remote
Employment Type: 6-month contract with potential for extension
Overview
We are seeking an experienced Systems Engineer to support risk management activities for 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 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 policies and procedures for design control and risk management.
Education: Masters 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).
- 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.
- Ability to manage complex systems and risk management processes.
- Strong analytical and problem-solving skills.
- Familiarity with regulated environments and design control processes.
- Full Legal Name:
- Current City State Zip:
- Interview Availability:
- Start availability:
- Work Authorization:
- Phone No:
- Hourly Rate:
Required Skills:
If you are interested please send your Updated Resume with the following info at the earliest; Full Legal Name: Current City State Zip: Interview Availability: Start availability: Work Authorization: Phone No: Hourly Rate:
Company Industry
IT Services and IT Consulting
Key Skills
- Children Activity
- Graphic Designing
- Information Technology
- FX
- Airlines
- Asic
