Abbott is looking to build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories.
Requirements
- Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304.
- Prior design control experience preferred.
- Knowledge of Jira, Confluence and/or other software development tools is a plus.
Responsibilities
- Lead/support design planning efforts to include heading cross-functional teams; establishing deliverables and tracking completion for complex projects
- Lead/support complex investigations and CAPA activities
- Drives alignment in cross functional meetings acting as QA representative on new and on-market product design projects to ensure compliance with the internal design control process and external standards and regulations.
- Contributes to the planning and execution of risk management for new products and supports the development of the risk management file.
- Reviews and approves engineering changes in a timely manner.
- Collaborates with R&D and Marketing to support mobile app deployment activities (for Software as a Medical Device projects).
- Drives alignment during cross functional review and approval of impact assessments, root-cause analysis investigation and resolution activities.
Other
- Bachelors Degree, or equivalent experience, in Engineering, Technical Field, Life Science, or closely related discipline.
- Minimum 5 years in applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
- Minimum 2 years’ experience in regulated environment such as medical devices or pharmaceutical products.
- Excellent oral and written communication skills.
- ASQ CQE or CSQE Certifications a plus.
