Senior Engineer - Modeling and Simulation

Role Summary

Senior Engineer - Modeling and Simulation

Responsibilities

• Identifying requirements and specifications suitable for in-silico evaluation of combination products.
• Applying finite element analysis (FEA) and modeling and simulation (M&S) principles to develop, deploy, enhance, automate, and manage in-silico models for combination products.
• Implementing in-silico models in commercial and proprietary software and deploying these models to internal users via enterprise modeling infrastructure.
• Demonstrating critical and analytical thinking skills to explore new opportunities in in-silico and data-driven computational models and simulate complaints and real-world issues within lifecycle of combination products.
• Providing positive leadership and delivering work in a fast-paced, multi-project, cross-functional environment.
• Demonstrating modeling and visualization approaches as part of proof-of-concept projects.
• Taking ownership of developing and managing backlog of in-silico product content in Scrum and SAFe (Scale Agile Framework).
• Collaborating with internal stakeholders such as design engineering, data scientists, and quality teams, and documenting the technical basis of the models for the broader engineering and scientific community responsible for design and manufacturing of drug delivery devices.

Qualifications

• Basic Qualifications:
  • Doctorate degree and relevant in-silico modeling experience with proficiency in commercially available tools, OR
  • Master's degree and 3 years of relevant in-silico modeling experience with proficiency in commercially available tools, OR
  • Bachelor's degree and 5 years of relevant in-silico modeling experience with proficiency in commercially available tools, OR
  • Associate degree and 10 years of relevant in-silico modeling experience with proficiency in commercially available tools, OR
  • High school diploma / GED and 12 years of relevant in-silico modeling experience with proficiency in commercially available tools.

• Preferred Qualifications:
  • Proficiency in mathematical and computational (in-silico) modeling, FEA for structural, fluidic, thermal, and multi-physics problems using software such as 3DEXPERIENCE SIMULIA, ABAQUS, ANSYS, LS-DYNA, and COMSOL.
  • Programming in Python and/or MATLAB; experience with GitLab or similar repositories.
  • Experience with mathematical/first principles modeling, numerical techniques, and uncertainty quantification (e.g., Monte Carlo) for design.
  • Experience with combination products, device regulatory requirements, medical device development and design controls, and process controls.
  • Strong communication, presentation, and technical documentation skills.
  • Intellectual curiosity and ability to learn new concepts quickly; ability to manage multiple priorities in cross-functional environments.

Skills

• In-silico modeling
• FEA and M&S
• Programming (Python, MATLAB)
• Version control (GitLab)
• Numerical methods and uncertainty quantification
• Regulatory knowledge for medical devices

Education

• Doctorate or Master's or Bachelor's degree or higher as specified in qualifications (in-silico modeling field).