USA Risk Manager CtQ

Skaneateles, NY - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Systems Engineer Risk Management Support

Location: Remote (CST hours 7 AM 6 PM flexible)
Duration: Contract (possibility of extension)

Overview:

Seeking an experienced Systems Engineer to support risk management activities for the Front Line Care Patient Monitoring Portfolio. The ideal candidate will act as a Subject Matter Expert (SME) in risk management working closely with cross-functional teams to ensure compliance with ISO 14971 and clients quality management system.

Key Responsibilities:

Support and guide risk management activities for patient monitoring products.
Partner with functional owners to plan update and maintain risk management files.
Communicate effectively with stakeholders including Quality Systems/Risk Project Management Regulatory Affairs and Marketing.
Translate stakeholder needs into design inputs and trace these through to design outputs.
Utilize operational functional and physical architectures to analyze potential hazardous situations.
Ensure all risk management work aligns with clients design control and risk management policies and procedures.
Contribute to continuous improvement of systems engineering and risk management practices.

Qualifications & Experience:

Masters degree in Systems Engineering (required).
INCOSE Certification preferred.
10 years of professional experience in systems engineering or related roles.
Experience in a formal systems engineering environment is required.
Medical device industry experience with Quality Management Systems highly preferred.
Software development and/or Electrical Engineering background a strong plus.
Proven ability to work collaboratively across multidisciplinary teams.

Preferred Skills:

Deep understanding of ISO 14971 risk management standards.
Familiarity with FDA design control requirements (21 CFR Part 820).
Strong analytical organizational and communication skills.
Experience managing end-to-end systems engineering processes from stakeholder needs to design outputs.

Job Title: Systems Engineer Risk Management Support Location: Remote (CST hours 7 AM 6 PM flexible) Duration: Contract (possibility of extension) Overview: Seeking an experienced Systems Engineer to support risk management activities for the Front Line Care Patient Monitoring Portfolio. The ...