Hello,

Hope you are doing well.

Role: Senior Risk Manager – Medical Devices

Location: Remote

Job Description:

We are seeking an experienced Senior Risk Manager to support risk management activities within the Front Line Care Patient Monitoring Portfolio. The ideal candidate will operate in a formal systems engineering environment and serve as a subject matter expert (SME) in risk management.

Responsibilities:

• Lead and support risk management planning and updates in compliance with ISO 14971 and company design control procedures.
• Collaborate effectively with cross-functional stakeholders including Quality, Systems/Risk, Program Management, Regulatory Affairs, and Marketing.
• Guide functional owners through all elements of the risk management file to ensure alignment with regulatory and business requirements.
• Apply systems engineering principles to identify stakeholder needs, translate them into design inputs, and ensure traceability through design outputs.
• Analyze operational, functional, and physical architectures to assess potential hazardous situations and develop effective mitigations.

Qualifications:

• Minimum of 10 years of experience in systems engineering, risk management, or a related discipline.
• Experience working in a formal systems engineering environment.
• INCOSE Certification preferred.
• Medical device experience and familiarity with Quality Management Systems (QMS) strongly preferred.
• Experience with software and/or electrical engineering development is a plus.