Validation Engineer Biomedical Jobs Near Me

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer

Let's do this. Let's change the world. 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.

• Develop,validate, qualify, and deploy advanced computational models (InSilico modeling assets) for combination products.

• Applyfirst-principles/analytical modeling, numerical methods,finite element analysis (FEA),surrogate modeling,andAI/ML techniquessolvecomplex 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.

• Identifymodeling assumptions, requirements, specifications, and acceptance criteriaappropriate forInSilico 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.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

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 n 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 ofEngineering Experience (Mechanical Engineering, Biomedical Engineering, or Civil Engineering)

Preferred Qualifications

• Demonstratedexpertisein 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,andDesign 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 inAgenticAI to deploy modeling assets and encourageexploration ofAI-enabled Insights

• Strong analytical and critical thinking skills.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.