Description
Key Features:- Participate as a member of cross-functional development teams for drug delivery systems.
- Support drug delivery projects with primary responsibility for risk management activities:
- Prepare for and facilitate risk assessments throughout the product development lifecycle.
- Provide risk mitigation recommendations from risk assessments to the system development team.
- Author and gain review and approval of risk management documents.
- Maintain coordination of risk management activities with product requirements and verification/validation activities.
- Provide estimates of risk management efforts to project management and participate in project scheduling.
- Maintain knowledge of and compliance with applicable standards and operating procedures.
- Provide expertise in systems engineering, with emphasis on risk management, in aiding development teams to understand the interactions of risk management with the overall product development process.
Skills & Experience:
- BS in Engineering and previous experience in a medical device industry
- 10 years current experience with engineering processes and procedures.
- Background in engineering and commercialization of electro-mechanical medical devices.
- Product design/development experience
- Experience in drug/device combination product design and development
- Familiar with the following standards:
- Quality System Regulation - 21CFR820
- Risk Management - ISO 14971
- EU Medical Device requirements - Council Directive 93/42/EEC
- Medical Electrical Equipment - EN 60601
- Small scale device assembly experience.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
To find out more about Real please visit www.realstaffing.com