Overview
On Site
Full Time
Skills
KPI
Product Design
Supply Chain Management
Process Modeling
Modeling
Medical Devices
Problem Solving
Conflict Resolution
Analytical Skill
Experience Design
Design Of Experiments
Writing
Prototyping
Communication
Management
Chemical Engineering
Science
Collaboration
Manufacturing
Job Details
Job Summary:
Roles & Responsibilities:
Education & Experience:
- 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.
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