In this Design Quality Engineer 2 - Risk Management role, you will be a quality engineer reporting into the Development Quality organization. You will be responsible for performing risk management activities associated with on-market in-vitro diagnostic (IVD) products ranging from Whole Genome Sequencing Platforms, Assays, Automation, and Software products in adherence to Quality Management System processes. This role will collaborate deeply with product SMEs in product development, manufacturing, as well as with Design Quality Engineering functions.
This role requires an intimate understanding of the following:
* Product Risk Management in accordance with ISO 14971:2019
* A highly disciplined approach to creating and maintaining risk documentation
* The ability to quickly grasp highly technical concepts associated with a large product portfolio.
- Bachelor's degree or higher in Engineering, Chemistry, Biochemistry or related disciplines.
-3+ years in quality assurance field in a regulated environment
- Demonstrated experience in executing and managing the complexities of system and sub-system level risk management activities like Hazard Analysis and Failure Modes and Effect Analysis (FMEA) in accordance with ISO 14971.
- Exceptional computer skills (specifically tool navigation, data entry, and collaboration) using web-based applications like SAP, Siemens Teamcenter, Confluence, Microsoft Office/Teams, etc.
- Direct experience working in in-vitro diagnostic or Medical Device development and/or manufacturing
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.