Process Engineer

Job Summary:

• Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews.
• 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

• Successful experience in scaling up multiple new formulations (from modeling through to production scale) is required. Experience in biomaterials and material development highly preferred
• Experience in Medical Device industry is preferred; experience in combination products is preferred. Experience with respect to PMA preferred
• Proven problem-solving skills using analytical technologies is preferred
• Experience in the following processes (at multiple scales) is required:
  Powder handling, filling, mixing, transport, isolation, polymer synthesis and reaction (more may be added)
• Experience Design of Experiments (DOE) is required.
• Experience in developing protocols and writing completion reports is preferred.
• Experience in vitro and ex vivo methods for characterizing prototypes and products is preferred
• Excellent communication, collaboration and influencing skills
• Demonstrated ability to deliver project outcomes in an ambiguous environment
• Requires experience managing self-directed work teams
• Travel up to 20% may be required (domestic and international)

• Bachelor's degree in the following is required Chemical Engineering, Polymer Science, Polymer Engineering
• Advanced degree is highly preferred.
• Collaborate with external suppliers, CDMOs and manufacturing facilities to develop processes.
• Drive selection of lab scale and pilot scale equipment.