What are the responsibilities and job description for the Senior Systems Engineer - Risk Management position at IPS Technology Services?
This is a remote position.Job Title: Senior Systems Engineer – Risk ManagementLocation: RemoteEmployment Type: 6-month contract with potential for extensionOverviewWe 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 ResponsibilitiesProvide expert guidance to functional owners on planning and updating elements of the risk management file.Support end-to-end processes:Identify stakeholder needsTranslate needs into design inputsTrace design inputs to design outputsAnalyze 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.QualificationsEducation: Master’s degree in systems engineeringExperience: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 AttributesAbility to manage complex systems and risk management processes.Strong analytical and problem-solving skills.Familiarity with regulated environments and design control processes.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:
