One Amgen Center Drive Thousand Oaks, California 91320 | Contract
Serves as a key medical device/combination products risk management expert .
Top 3 skill sets needed:
- A good functional understanding and 10+ years of experience in systems engineering and risk management for medical devices. (Electric, System, mechanical Engineering Experience).
- Risk management FMEA (Failure Mount Effect Analyst), design facilitation.
- Good technical writing skills and capable of managing multiple concurrent projects, facilitating technical discussions among subject matter experts from different functions
- Conducting the device risk management process of assessment (identification, analysis and evaluation), mitigation (reduction, acceptance, communication) and review of risk during device development and manufacturing.
- Program development responsibilities will also include the continued advancement in risk assessment methods, tools, measuring, scoring, prioritizing and alignment with device development practices.
- Ensures Quality Risk Management are in alignment with 21CFR Part 820 design control and risk management requirements
- Ensures implementation of existing Device Risk Management Program in the Device development Process and Post-Market surveillance process
- Conducts risk assessments and completes risk management deliverables required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations.
- Specific risk management deliverables include: risk management plans, risk management files, hazard analyses, user risk assessments, design risk assessments (e.g. device component, system level), process risk assessments.
- Completes activities as necessary to maintain risk management documents as new information is learned during the development process or per signals obtained through post market surveillance programs.
- Analyzes design changes from systemic perspective, identifying risks, driving design mitigations and evaluating effectiveness of the risk control measures.
- Organizes appropriate device risk reporting using established quality systems
- Successfully influences outcomes, communicates with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting
- Requires and advanced degree and have 8 years industry experience with Fault Tree Analysis, and/or other risk analysis methods such as FMEA for medical devices
- Strong working knowledge of ISO 14971,
- Previous experience in a Medical Device Development or Device Risk Management role
- Familiar with the following standards:
- US Good Manufacturing Practices – 21CFR820
- Quality Management – ISO 13485
- Medical Electrical Equipment – EN 60601
- Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
- Strong problem solving, risk assessment, and risk management skills
- Ability to converse technically with mechanical, electronic, software, and quality engineers
- Must be capable of working on multiple projects in a deadline driven environment
- Must have strong oral and written communication skills, decision making, and presentation and organization skills, to collaborate with Hardware, Software, Systems Engineers, and domain experts in the area of design and safety risk analysis.
- Proven ability to collaborate with various design/cross-functional teams such as clinical, patient safety and influence product development teams to drive system safety into product design.
- Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach
- Organizational savvy and presence to build effective relationships across functions
- Track record of building or participating as a member of high performing teams