Principal Scientist, Combination Product Physics Based Modeling and Simulation Combination Products

Job Description

We are seeking a Principal Scientist to lead physics-based modeling and simulation within the Device Product Assessment and Innovation team in Device Development and Technology. The role connects drug delivery device physics with translational modeling of the delivery environment, tissue interactions, and pharmacokinetics/pharmacodynamics (PK/PD), partnering with teams to link formulation, device performance, and biological response. The role sets cross-program strategy, advances shared data and decision science capabilities, and provides independent scientific judgment, cross-functional influence, and scientific mentoring.

Responsibilities:

• Set cross-program modeling strategy linking device physics with physiologically representative delivery environments and translational PK/PD insights, aligned with portfolio priorities and manufacturing digital twin capabilities.
• Lead first-principles modeling of formulation mechanics, flow paths, actuation, and tissue interactions; integrate tissue phantoms and delivery-environment digital twins with translational partners to guide specifications and reduce physical testing.
• Set model development, verification, validation, and uncertainty standards; oversee scientific review for credible, reproducible, fit-for-purpose results.
• Partner with translational and PK/PD experts to integrate delivery-environment properties, biometrics, formulation attributes, and device performance with exposure and biological response; assess preclinical-to-human translation and inform governance decisions.
• Advance reusable models, shared data workflows, decision science, and appropriate AI methods across the three partner groups; prioritize capability investments and external collaborations, and mentor scientists.
• Lead modeling contributions to design controls, validation protocols, and regulatory submissions with Quality and Regulatory; represent the function in scientific forums, publications, conferences, and consortia, as appropriate.

Qualifications:

• Bachelor’s + 12 years, master’s + 9 years, or PhD + 6 years of relevant experience in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related engineering discipline.
• Extensive physics-based modeling and simulation experience addressing complex engineering or scientific problems; ability to transfer methods across applications. Device, drug delivery, or combination product experience is preferred, not required.
• Advanced simulation and programming skills (e.g., MATLAB, ABAQUS, ANSYS, COMSOL, Python, C++), including method selection and robust, reusable workflows.
• Demonstrated cross-program or platform scientific leadership, independently resolving complex problems and evaluating model credibility and uncertainty to guide decisions.
• Demonstrated cross-functional and senior-stakeholder influence, clear communication of technical trade-offs, and scientific mentoring in a matrixed environment.
• Experience with rigorous model verification, validation, uncertainty assessment, and technical documentation; ability to build working knowledge of device development expectations in partnership with domain experts.

Required Skills:

Biomedical Engineering, Combination Products, Cross-Functional Communications, Drug Delivery, Finite Element Analysis (FEA), Human Factor Engineering, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Next Generation Science Standards, Pharmacokinetics, Physics Simulation, Process Development Engineering, Risk Management, Simulation Programming

Preferred Skills:

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