You will own the development, optimization, and scale-up of implantable cell encapsulation devices and manufacturing processes.
Responsibilities
Design and develop equipment, processes, and control systems for production and assembly.
Identify process technologies, develop proofs of concept, prototype, and validate processes for commercialization.
Write and report protocols, reports, SOPs, and work instructions while coordinating testing execution.
Characterize processes statistically to implement controls ensuring repeatability and consistency.
Perform engineering analyses, physical testing, and 3D CAD modeling to support rapid development cycles.
Required Skills
Bachelor's degree in engineering or relevant discipline with 10 years of experience in process development/optimization within medical device or GMP regulated environments (8+ years with Master's, 4+ years with PhD).
Experience leading high-complexity new process development initiatives from concept through execution and qualification.
Proven ability to act as a technical project manager coordinating cross-functional teams.
Strong understanding of statistical principles, technical writing, and presentation skills.
Knowledge of global cGMP requirements governing device or combination products.
Experience with polymer processing, including injection molding, roll-to-plate printing, and polymer coating.
Experience with polymer joining techniques such as thermal staking, ultrasonic, or laser welding.
Ability to manage equipment evaluation, selection, and modification for new processing technologies.