Risk Management Engineer

Title: Risk Management Engineer

Location: Murrysville, Pennsylvania, United States

Duration: 12+ months

3 days onsite/week

Role:

Key developer in expanding the Quality & Regulatory Risk Management team for the Sleep and Respiratory Care organization.

Create and implement new tools and methods to manage risk, contributing to the safety and efficacy of medical products that save lives and improve health.

Responsibilities:

Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.

Lead cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.

Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.

Analyze existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.

Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.

Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.

Create and continually improve procedures and work instructions to ensure reliable, repeatable results. Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.

Skills/Education:

BS in Engineering or a related field. MS preferred.

6+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.

2+ years experience with a MS or higher.

Extensive hands on experience with the ISO 14971 standard.

Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.

Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.

Demonstrated expertise in managing complex projects and implementing cultural change.

Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.

Experience working within a Quality Management System.

Green Belt or Black Belt certification preferred.

Excellent team work skills including influencing and building rapport with internal customers and stakeholders.

Permanent