AbbVie is looking to solve serious health issues today and address the medical challenges of tomorrow by developing, launching, and maintaining medical devices and drug/device combination products.
Requirements
- experience with medical device or combination products including: product requirements: DHF traceability, impact assessment, and change management, risk management, and design validation
- familiarity with device design controls, to enable new product introduction and lifecycle management
- experience with identifying and deploying new methods and approaches within an organization
- strong problem solving, decision making, negotiation skills
- experience with regulatory standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971)
- experience with design validation activities
- experience with risk management files
Responsibilities
- managing a team of Systems Engineers and integrating input from multiple disciplines to assure accurate and compliant Design History Files
- leading the team to ensure that all DHF documentation adheres to regulatory standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971) and company procedures
- supporting product development, design changes, regulatory submissions, and audit readiness
- establishing risk management files and design validation activities for new product introductions
- standardizing and simplifying systems engineering activities to enable more efficient development and marketed product support
- identifying and leading continuous improvement initiatives within systems engineering and the broader combination product organization
- interfacing with 3rd party vendors
Other
- management experience that includes managing internal and external engineering teams
- Bachelors Degree in Engineering, science, or closely related discipline is desired or equivalent technical experience plus demonstrated competence
- 8+ years’ experience including: work as an individual contributor building technical expertise and proved project management skills
- business acumen coupled with leadership experience is required to drive high performance
- travel will be required, as necessary (10%)
