About the position
This position reports to the Combination Product Technology Development Manager. As part of the BD/ZebraSci Combination Product Services team, the Combination Product Technology Development/Device Engineer will assist with technical and scientific activities related to combination product technology, test method development and execution, and technical contact for the ZebraSci Marketing/Operations team. This position performs technical analyses of drug delivery systems, designs fixturing, develops and validates test methods, and helps implement new testing technologies with minimal supervision. S/he will assist in planning, performing, and analyzing bench-level engineering tests or research experiments for drug-device combination products and medical devices. The position requires that the candidate develop and transfer various tests, including but not limited to Design Characterization, Design Verification, and Batch release testing, to support operations.
Responsibilities
- Supports in scoping testing approaches, fixture design, and data analysis.
- Authors test methods, test protocols, test method validations, and test reports with minimal supervision.
- Coordinates with the Technology Development team to discuss and resolve challenges with service projects.
- Supports technical initiatives related to combination products testing services, methodologies, and instrumentation.
- With minimal supervision, implements new equipment programs, tests, methods, instrumentation, and procedures.
- Plans and performs experiments that support new product or technology feasibility testing.
- Develops new methodologies or conducts routine procedures as needed.
- Interfaces with machine shop to execute fixturing development and fabrication to support experimental designs.
- Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment.
- Keeps a working knowledge of commonly prescribed methods, background information, and troubleshooting strategies, including cGMPs and relevant ISO and ASTM guidelines.
- Adheres to ZebraSci Quality Systems, including timely identification and notification of potential Quality Events.
- Follows established Standard Operating Procedures, makes recommendations for edits, enhancements, and/or new procedures.
- Assists with edits, review, issuance, and archiving of quality system documents as needed.
- Effectively communicates orally and in written project progress and results within the Technology Development and Operations Team.
- Skilled in effectively presenting and communicating performance results and test outcomes.
- Communicates challenges, scheduling or testing conflicts, and other issues to management in a timely manner.
- Provides guidance to lab staff when needed.
- Understands documentation requirements per cGMP.
- Able to troubleshoot and provide technical assistance for Root Cause Investigations.
- Assists staff, including activity training and oversight when needed.
- Works and communicates openly and collaboratively with colleagues and staff.
- Responsible for maintaining the lab and storage areas in a clean and organized manner.
- Demonstrates project planning and organization skills to balance a multitude of projects simultaneously.
- Supports the Services Technology Development Management, as needed.
- Support other activities and duties as needed or assigned.
Requirements
- Education: Bachelor's or master's degree in mechanical/biomedical/chemical/electrical/software or relevant engineering discipline.
- 3-5 years of experience with a Master's degree, OR 5-7 years of experience with a Bachelor's degree.
- Relevant experience related to combination product or medical device development and/or testing.
- Ability to work on-site at least 4 days per week.
Nice-to-haves
- Experience with test method development and validations.
- Knowledge of GLP, cGMPs, 21 CFR820.30, ISO and ASTM procedures.
- Proficiency in CAD (SolidWorks) for fixture designing.
- Knowledge of 3D printers for rapid prototyping and fixture development.
- Strong experience with statistical and analytical methods, including Design of Experiments and ANOVA analysis.
- Proficiency in statistical software such as Minitab and JMP.
- Knowledge of drug-device combination products and/or medical devices.
- Experience with mechanical measurement equipment (e.g., Instron, Zwick), vision systems (Keyence), and container closure integrity instrumentation.
- Technical document generation, execution, and reporting experience.
- Strong communication skills (both written and oral).
