Job Location: North Chicago - IL
Experience: 3-5 Year
- Design Controls experience – from early stages to validation and transfer (MUST HAVE)
- Pre-filled syringes experience (MUST HAVE)
- Experience with PFS with biologics (filling, packaging, sterilization) (MUST HAVE)
- Expertise in medical device development (MUST HAVE)
- Demonstrated knowledge of research and development aspects from product concept to product launch, including design and process development, vendor communication, protocol creation, design, testing, and documentation.
- Complete understanding and application of technical principles, theories, and concepts in the field of parenteral delivery.
- Experience working in a general engineering laboratory setting related to medical device development.
- Ability to comprehend and apply principles of advanced math and statistical theory (to include t-tests, f-tests, tolerance limits, etc.).
- Knowledge of GMPs, ISO standards related to the pre-filled syringes development and manufacture.
- Ability to effectively interact with CMOs to transfer designs into production.
- Ability to travel at least 10% of time.
- Contributes to the completion of major programs and projects, guides the successful completion of minor programs
- Provides technical assessments for business development decisions as needed. Provides technical solutions to a wide range of difficult and complex problems.
- Providing general and technical guidance to the team, as needed.
Collects, organizes and analyzes technical information to support the development and design of products. - Performs technical and statistical analyses in the form of written reports.
- Identifies technical opportunities and provides analysis to demonstrate concept while meeting key specifications.
- Provides support to other departments as necessary to support production or product development.
