Process Engineer

Responsibilities

• Product formulation and launch experience.
• Biomaterials and material development.
• Knowledge of Medical devices and combination products; PMA familiarity.
• Problem-solving using Analytical tools.
• Knowledge of Design of Experiments (DOE).
• Protocol development, reporting, and documentation.
• In-vitro/ex-vivo characterization of prototypes.
• Strong communication and collaboration across teams.
• Ability to work in ambiguous environments and deliver outcomes.
• Experience with self-directed teams and multitasking.
• Effective prioritization and decision-making.
• Travel up to 20% may be required (domestic and international)
• Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews.
• Collaborate with external suppliers, CDMOs and manufacturing facilities to develop processes. Drive selection of lab scale and pilot scale equipment.
• Drive process and product characterization to ensure rigorous technical understanding meets scale-up metrics and KPIs (such as scrap, cost and quality)
• Lead raw material suppliers through raw material iterations, correlating to product design window
• Drive execution of Learning Plans, seamlessly collaborating with Supply Chain
• Peer review, coach and develop earlier in career engineers with respect to Process Design