5-7 years of experience in scaling new formulations from modeling to production scale
Bachelor's degree in Chemical Engineering, Polymer Science, or Polymer Engineering required
Advanced degree preferred
Experience in the Medical Device industry, particularly with combination products and PMA
Strong experience in Design of Experiments (DOE)
Proficient in problem-solving with analytical technologies
Ability to work with self-directed teams and manage complex projects
Responsibilities
Lead the design and qualification of processes from modeling to pilot scale
Ensure product characterization meets scale-up metrics such as quality and cost
Guide raw material suppliers through iterations corresponding to product design
Execute learning plans in collaboration with Supply Chain teams
Peer review and mentor junior engineers in process design
Benefits
Opportunity for professional development and growth
Collaborative environment with cross-functional teams
Involvement in innovative medical device projects
Potential for travel to suppliers and manufacturing facilities
Exposure to a dynamic and fast-paced work environment
Full Job Description
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
Roles & Responsibilities:
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)
Education & Experience:
Bachelor's degree in the following is required Chemical Engineering, Polymer Science, Polymer Engineering
dvanced degree is highly preferred.
Collaborate with external suppliers, CDMOs and manufacturing facilities to develop processes.
Drive selection of lab scale and pilot scale equipment.
