Engineer II
BioSpace · Thousand Oaks, CA · 1 mo ago
Engineering$103k–$118k/yrFull-time
Duties
- Author design control and technical documents for design verification and characterization, including test plans, test protocols, test reports, and technical assessments;
- Hands-on testing of combination products (drug product-filled syringe with an autoinjector device), including the safe operation of test equipment and devices containing sharps (syringes);
- Develop verification/characterization testing strategies by separating them into platform and combination product testing to ensure minimum redundancy and maximum efficiency for clinical/commercial development and design verification stages of multiple programs;
- Ensure test methods and test protocols are developed in a sound and robust framework with a high focus on eliminating test errors;
- Collaborate with and support manufacturing team on the inspection of the subassemblies and build plan of the combination products;
- Provide mechanical design support and insights from the testing results to the mechanical engineering design team, method development team, and digital workstream team to enhance design, method, and documentation;
- Give to and be responsible for the implementation of drug delivery design projects in different therapeutic areas, including rheumatology, dermatology, cardiology, and endocrinology;
- Develop, implement, and review design and development plan, combination product specifications, design input requirements documents, and other related development documents for assigned projects;
- Provide technical feedback for mechanical problems to programs as needed.
Requirements
- Masters degree (or foreign equivalent) in Mechanical Engineering, Biomedical Engineering or related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the following:
- Mechanical system design, development, and testing;
- 3D CAD modeling and engineering drawings using SolidWorks;
- Prototype fabrication and benchtop experimental verification and validation;
- Lab instrumentation and test data acquisition;
- Material selection and evaluation for mechanical components;
- Design optimization and performance evaluation;
- Finite Element Analysis (FEA) and numerical modeling;
- Experimental design and data analysis for performance characterization;
- Technical documentation and scientific writing;
- Test setup and fixture design for device and mechanical evaluation.
Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job#R-244941.
Job type: Full Time
The annual salary range for this position in the U.S. is $102,679.00 - $117,995.00 per year.
Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation.
For more details visit https://careers.amgen.com/life-at-amgen/benefits/.