Engineer - Computer-Aided Engineering (DDCS)

About This Role

Develop, execute, and interpret computational models to support medical device development and optimization, ensuring technical risk mitigation and regulatory compliance. This role involves building reusable simulation frameworks, communicating complex results to diverse stakeholders, and collaborating with cross-functional teams to advance life-changing medicines.

Responsibilities

• Develop, execute, and interpret in silico models to support device development, design optimization, and technical risk mitigation
• Build reusable simulation frameworks, material libraries, and standardized workflows to improve efficiency and consistency
• Communicate modeling assumptions, methods, and results to cross-functional stakeholders, including non-technical audiences
• Author and review technical reports and regulatory submission content (IND/CTX, CTD) related to computational modeling
• Define physical testing requirements in collaboration with internal teams and external partners to support model input and validation activities
• Manage external vendor relationships for modeling support and component design evaluation
• Evaluate emerging simulation methodologies, regulatory expectations, and industry practices; recommend and implement relevant advancements
• Contribute to model governance and credibility assessment frameworks aligned with ASME V&V 40
• Collaborate with cross-functional teams, including Formulation Science, Device Engineering, Quality, Regulatory, and Manufacturing
• Maintain a quality mindset by identifying issues proactively and supporting continuous improvement

Requirements

• 3+ years of FEA experience
• Expertise in commercial FEA solvers (e.g., Abaqus, ANSYS), including nonlinear analysis, contact mechanics, and material modeling (hyperelastic, viscoelastic, plasticity)
• Proficiency in preprocessing tools (e.g., HyperMesh)
• Proficiency in scripting languages (Python, MATLAB, or solver-native)
• Working knowledge of ASME V&V 40 and FDA guidance on computational modeling for medical devices
• Familiarity with medical device design controls (ISO 13485, 21 CFR Part 820)

Qualifications

• MS in Mechanical Engineering, Biomedical Engineering, Computational Mechanics, or related field
• 3+ years of FEA experience

Nice to Have

• Experience with multiphysics simulation (e.g., COMSOL, Ansys Fluent)
• Exposure to ML/AI applications in simulation (surrogate modeling, design space exploration)
• Familiarity with model-based systems engineering, digital twin concepts, or uncertainty quantification methods
• Knowledge of materials and components common to pharmaceutical delivery systems (injection-molded plastics, elastomers, glass/polymer containers, spring mechanisms)
• Experience with design for manufacturing principles

Skills

* Required skills

Benefits