Assist with the development of products, processes and packaging within the MTF Design Control System. Provide technical support for scale-up of process, product and packaging development activities for transition from R&D to Manufacturing.
1. Participate in the development of mechanical, physical, chemical or biologic test methods and test protocols; perform tests and record information; provide reports required to meet Design Control requirements.
2. Generate basic statistical summaries and reports from collected data.
3. Contribute to product and packaging design, prototyping and testing.
4. Participate in the development of processes for new products, including process design, equipment procurement and process validation.
5. Perform record keeping for all experiments and research activities in compliance with GLP guidelines.
6. Assist with the planning and execution of Design of Experiment (DOE) activities to establish product or process specifications.
7. Work with a team to transfer lab-scale product, process and packaging to the manufacturing and quality organizations as part of scale-up activities including training, documentation and validations.
8. Conduct product and/or packaging stability studies. Provide reports and analysis.
9. Assist on special projects and perform additional duties as assigned.
1. Bachelor’s degree in engineering discipline (e.g. Mechanical, Biomedical, Chemical, Materials Science).
2. Proficiency in Microsoft Word and Excel, and basic statistical analysis. Knowledge of test design software. Knowledge of CAD design software associated with solid modeling and drafting are a plus.
3. Strong written and verbal communication skills. Ability to work within a multifunctional team environment.
4. Ability to work independently with basic supervision.
5. Experience working in a laboratory environment is desirable.
6. Completion of senior project as part of undergraduate degree and internship/co-op experience desired.
Musculoskeletal Transplant Foundation - 2 years ago
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