| Job Description: |
Must Have Technical/Functional Skills
· Product formulation and launch experience.
· Biomaterials and material development.
· Medical device and combination product design and development; PMA familiarity.
· Problem solving using Analytical tools.
· Design of Experiments (DOE) and applied statistics.
· Protocol development, reporting, and documentation.
· In-vitro/ex-vivo characterization of prototypes.
· Biochemical test method development and validation.
· 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)
Roles & Responsibilities
· Leads formulation design efforts from concept through to prototyping phases, Design Reviews and Validation
· Collaborate with external suppliers and internal partners to develop products
· Drive product characterization to ensure rigorous technical understanding and relationships to pre-clinical/clinical outcomes
· Lead raw material suppliers through raw material iterations, correlating to product design window
· Drive execution of Learning Plans
· Participate in multi-functional discussions and design reviews, including product creation at multiple scales (modeling, lab, pilot and manufacturing)
· Participate in clinical procedures and activities, translating learning into viable prototypes
Generic Managerial Skills,
· Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
· Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
· Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
· Ability to understand and follow complex written procedures is required.
· Ability to function in a team environment and deliver on team objectives is required.
· Ability to make decisions and solve problems while exhibiting situational judgement
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