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Senior Combination Products Engineer
2 months ago
This is an onsite position. The candidate will need to be a US Citizen or Green Card holder.
Contractor Engineer Combination Products
Overview
The Contractor Engineer Combination Products operates under technical guidance on project teams dedicated to combination products and medical devices. Responsibilities encompass contributing to product design documentation and executing laboratory evaluations of product performance to support product development, manufacturing transitions, supplier-driven design modifications, and product improvements. The products are designed for drug delivery and include plastic disposable and implantable items, injection devices, and electromechanical devices with integrated software. Work is conducted in accordance with device design controls (FDA 21CFR820.30 and/or ISO as applicable). Furthermore, the role entails developing product knowledge through initiatives that involve understanding existing competitive products in the market, materials research, and computer simulations.
Key Responsibilities:
- Conduct independent laboratory work and data analysis with a focus on mechanical testing.
- Perform documentation analysis and prepare technical transfer documentation.
- Create technical documentation for products in development.
- Prepare design change documentation for existing products.
- Design, develop, and construct experimental fixtures/jigs in collaboration with vendors.
- Troubleshoot experiments and instrumentation.
- Learn and comprehend new experimental techniques.
- Demonstrate proficiency in multiple techniques and modify protocols as necessary.
- Contextualize data appropriately by consulting and citing relevant literature.
- Exhibit technical proficiency in the performance characterization of medical devices.
- Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls, and GxP compliance.
- Proficient in technical transfers and design control principles for medical devices.
- Proficient with documentation management systems.
- Proficient with CAD, design principles, GDT, and data management systems.
- Proficient in a laboratory environment with an emphasis on mechanical testing.
- Experienced in rapid prototyping technologies and equipment.
- Able to work in a regulated environment.
- Familiar with laboratory environment, safety practices, and Electronic Notebook handling.
- Familiar with tool room environment, metrology, and CMM principles.
- Applies basic computer skills in support of data analysis.
- Applies technical writing skills to produce technical protocols, reports, and other documents.
- Works under the direction of senior staff.
- Summarizes and presents project results to project teams.
- Able to train other staff members on experimental methods, protocol procedures, manufacturing, and prototyping techniques.
- Independently executes laboratory studies and proposes enhancements to laboratory capabilities and processes.
- Bachelor's Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials Science, or a related field with 5+ years of experience.
- Master's Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials Science, or a related field with 3+ years of experience.
