Position Objective The Life Technologies Companion Diagnostics team located in Pleasanton, CA is looking for an individual who has the drive and passion to join our quest in the evolution of personalized medicine. You will have the opportunity to directly impact patients through the design and development of leading edge IVD systems. Talented individuals who share our beliefs should apply for this position to help develop IVD systems to benefit patients in ways not possible before. The Systems Engineering Group holds two key components in the Companion Diagnostics group. First is to ensure all hardware, disposables, software and reagent components work seamlessly together. Moreover, Systems Engineering Group handles the system verification and validation per FDA PMA requirements. This includes the integration of several instruments which are part of a workflow (e.g. sample prep and amplification/detection/sequencing instrument), the software to control and connect the instruments as well as interpreting and reporting patient results, disposables and reagents. This group will also provide service to the reagents team to maintain “the system” during IVD assay development. Essential Functions

• The Staff IVD Systems Engineer will report to the Senior Manager of Systems Engineering and be responsible for development and integration of different IVD Systems components.
• Further the successful candidate will be responsible for supervising the system verification and validation activities to ensure the IVD product follows the design control.
• This position will also oversee the systems software development and works closely with quality control and regulatory affairs to ensure the newly developed system meets all regulatory IVD requirements of its target market.

Experience Requirements

• Must have demonstrated understanding of what is needed to support a system in the diagnostics market.
• Solid verification and validation experience at system level for IVD products.
• Observed the full cycle of an IVD product development from concept phase to commercialization at system level within an ISO 13485 / QSR compliant environment.
• Familiar with design control and good ability to design, validate, perform and analyze experiments to characterize the performance of products relative to product performance and customer requirements.
• Collaborate with Assay Development, Quality, Operations and other functions to demonstrate assay feasibility and product concepts; conduct assay development optimization on the integrated platform; assay and system verification & validation; development of manufacturing processes, procedures, test methods and specifications; as well as transfer to sustaining organizations.
• Align with Regulatory and Clinical staff to conduct and document the studies necessary for 510(k), PMA, and worldwide regulatory submissions.
• Strong scientific background and hands-on experience on bio sample preparation, extraction, PCR, detection, and sequencing.
• Solid understanding of statistical concepts, including the bioinformatics required for the analysis and interpretation of scientific data.
• Analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.
• Willingness to be flexible and adaptable in a complex, matrix environment and be able to execute and complete the tasks/goals on time with self-motivation.
• Work within a diverse team and contribute to a positive work environment.
• Ability to influence stakeholders in other functions over whom the Systems Engineering Manager has no direct authority.
• Able to adapt to changing needs and parameters caused by time, budget, or other constraints. Acts as a mentor/role model for team members.
• Familiar with Agile, JMP and MS Office.

Minimum Qualifications (must have) Ph.D. with 3+ year experience in a life science, chemistry, physics or equivalent degree in engineering is preferred. A Master degree with 5+ year experience is acceptable in combination with adequate experience and track record. Preferred Qualifications (nice to have)

• Worked on a “Systems Team” which successfully launched an IVD product (e.g. European CE-IVD, Japan IVD or FDA - PMA preferred approval).
• Have good understanding of the global molecular diagnostics market.