Description

You will own the development, optimization, and scale-up of implantable cell encapsulation devices and manufacturing processes.

This role is on-site.

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.
• 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.
• Proficiency with Solidworks and 3D CAD software.

Preferred Skills

• Experience with DMAIC problem solving.
• Master's degree with 8+ years of experience, or PhD with 4+ years of experience.

Key Skills

Education

Bachelor's degree