As the Reliability Engineering Product Risk Specialist you will manage risk-based activities during product development to ensure the inherent safety of medical devices in use. Develop in-depth understanding of the use environment, clinical users, and procedures to guide project teams in the deployment of risk management processes. Support post market surveillance activities to maintain market safety and regulatory compliance.
Key Result Areas of the Reliability Engineering Specialist
• Provide technical subject matter guidance & training to others on Product Risk Management processes and techniques.
• Coordinate the Product Risk Management activities on projects and support the maintenance of project Risk Management Files.
• Review and remediate legacy product risk management files to ensure compliance to current risk management regulations/standards.
• Support Post Market Surveillance risk management activities to ensure continued adherence to standards as well as maintaining the safety and performance of devices on the market.
• Maintain internal risk management processes and procedures.
• Identify gaps in consistency of approach, application, understanding of the theme, and propose countermeasures and/or improvements.
• Maintain a strong and current understanding of the product risk management discipline and associated regulations/standards.
Have awareness and deep understanding of all applicable laws, standards, guidance’s, and requirements of product risk management.
2. Transfer information from all relevant laws, standards, guidance’s, and requirements into lean internal processes (including process ownership) to foster efficient and compliant product development and life cycle management.
3. Generate or manage all applicable risk management documentation in compliance with external standards and internal processes during product development as well as product lifecycle management.
4. Participate in internal and external expert working groups (e.g., standard development committee) to influence preparation and/or understanding of relevant upcoming regulations.
5. Interact with parallel functions in other group companies to facilitate global harmonization and contribute to Olympus success.
6. Roll out projects and activities in product risk management.
7. Act as internal and external consultant in diverse interfaces (e.g., other departments, S-BC, Customers).
8. Support the generation of timelines, cost and resource estimates for risk management-based tasks and activities to appraise management of performance against plan, communicating and reporting progress to project management to maintain and track compliance to project schedule.
9. Shall implement and work to all applicable regulatory and quality requirements as stipulated within the Quality Manual, Quality Policy, and Quality Objectives.
Education qualifications
• Bachelors or master’s degree in Engineering or equivalent professional or equivalent skill and knowledge gained through significant practical experience Job specific requirements
• Educational qualification in a Risk Management related discipline
*Qualifications and Experience are mandatory unless otherwise stated
Experience
• Experience in a regulated and highly industrial or scientific engineering design environment
• Project Experience
• Experience and understanding of intellectual property
• Experience in medical device development (preferred) Job specific requirements
• Applied knowledge and detailed understanding of Product Risk Management processes
• Proven experience of the tools and techniques required to apply Risk Management to products in development and post launch
*Qualifications and Experience are mandatory unless otherwise stated
Specific skills
• Relevant technical knowledge in the application product risk management techniques and processes
• Strong problem-solving skills independently
• Promote collaboration in a team
• Ability for proactive identification of opportunities for business success or efficiency improvement
• Understanding interfaces between functions, understanding of the needs of others.
• Statistics (preferred)
• Reliability Engineering (preferred) Job specific requirements
• Understanding of current medical device Risk Management standards (i.e., BS EN ISO 14971, PD ISO/TR 24971, PD IEC/TE 80002-1, & BS EN IEC 60812 • Knowledge of FDA and MDR requirements for the application of Risk Management to medical device design is highly desirable