Senior Engineer - Modeling & Simulation
BioSpace · Thousand Oaks, CA · 1 wk ago
EngineeringFull-time
About the role
Join Amgen’s mission of serving patients. In this vital role, you will collaborate closely with Design Engineering, Quality, Systems Engineering, Manufacturing, Process Development, Data Science, Regulatory, and Digital Technology teams to deliver enterprise-level modeling capabilities for prefilled syringes, autoinjectors, and other combination products.
Responsibilities
- Develop, validate, qualify, and deploy advanced computational models (InSilico modeling assets) for combination products.
- Apply first-principles/analytical modeling, numerical methods, finite element analysis (FEA), surrogate modeling, and AI/ML techniques to solve complex mechanical, structural, fluidic, thermal, and multi-physics problems.
- Develop digital models that improve understanding of device performance, design robustness, failure mechanisms, and system behavior throughout the product lifecycle.
- Build computational models supporting design verification and validation, design space development, manufacturing robustness, root cause investigations, complaint investigations, lifecycle management, new product development, and feasibility assessments.
- Identify modeling assumptions, requirements, specifications, and acceptance criteria appropriate for InSilico evaluation of combination products.
- Analyze simulation results and communicate engineering insights to support technical decision making, specification development, and risk reduction.
- Explore novel computational approaches, automation strategies, AI-enabled engineering methods, and data-driven modeling techniques.
- Develop proof-of-concept modeling solutions for emerging engineering challenges and complex product behaviors.
- Collaborate with multidisciplinary teams across Product Development, Manufacturing, Quality, Regulatory, Data Science, and Systems Engineering.
- Contribute to project planning, backlog prioritization, Agile/Scrum activities, and continuous improvement initiatives.
- Communicate complex technical concepts through clear reports, presentations, and engineering documentation.
- Promote modeling and simulation best practices across the organization.
Requirements
Basic Qualifications:
- Doctorate degree in Mechanical Engineering, Biomedical Engineering, or Civil Engineering (related to computational modeling and simulation).
- OR Master’s degree in Mechanical Engineering, Biomedical Engineering, or Civil Engineering and 2 years of relevant experience in computational modeling and simulation.
- OR Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or Civil Engineering and 4 years of relevant experience in computational modeling and simulation.
- OR Associate’s degree and 8 years of Engineering Experience (Mechanical Engineering, Biomedical Engineering, or Civil Engineering).
- OR High school diploma / GED and 10 years of Engineering Experience (Mechanical Engineering, Biomedical Engineering, or Civil Engineering).
Qualifications
Preferred Qualifications:
- Demonstrated expertise in physics-based modeling of mechanical systems.
- Programming experience in Python, MATLAB, or C++.
- Finite Element Analysis (FEA) experience with structural, contact, nonlinear, fluidic, thermal, and multi-physics problems.
- Experience with SIMULIA / 3DEXPERIENCE (preferred), ABAQUS, ANSYS, LS-DYNA, or COMSOL.
- Experience with surrogate modeling, reduced-order modeling, AI/ML-enabled engineering workflows, or data-driven prediction methods.
- Experience with Git or GitLab, version control, CI/CD workflows, and model automation.
- Experience with uncertainty quantification, sensitivity analysis, Monte Carlo simulation, and Design for Six Sigma (DFSS) methods.
- Knowledge of combination products, medical device development, design controls, V&V, and FDA-regulated environments.
- Strong technical documentation, presentation, and cross-functional communication skills.
- Intellectual curiosity and ability to learn new frameworks, algorithms, and technologies rapidly.
- Ability to manage multiple priorities and work effectively in a highly collaborative environment.
- Interest in Agentic AI to deploy modeling assets and encourage exploration of AI-enabled insights.
- Strong analytical and critical thinking skills.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Pay
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.