Job Description:
Differentiated Drug Delivery (DDD) is a combination product design and development organization focused on improving patients’ lives through customer-focused innovation and broad-based access to quality medicines and products.
- This role has primary responsibility for confirmation that medical devices and combination products meet their intended function.
- This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions.
- The candidate will work within a team environment to solve problems and utilize
- best engineering practices and techniques for root cause and statistical analysis.
- This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.
Responsibilities
- Partner with Systems engineers in defining product requirements such that they are verifiable
- Development of test fixtures, test methods, and performance of Test Method Validation activities
- Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
- Ensure integrity and compliance of data according to Standard Operating Procedures
- Develop Verification Plans including test strategy
- Utilize technical writing and statistical data analysis skills to write protocols and reports
- As necessary, conduct root cause analysis and derive recommendations based on analysis of data
- Translate inspections and tests methods into component and product specifications
Qualifications
- B.S. in Engineering or science discipline and 2 to 5 years related experience.
- Familiarity with ISO standard test methods and related test instrumentation preferred.
- Excellent analytical and communication skills required.
- Ability to work and solve problems in team environment.
- Technical writing skills are required for protocol and report writing.
Physical/Mental Requirements
- Physical requirements include walking, standing, and performing analysis including protocol and report writing. Includes hands-on test method development.
What is the minimum education experience required?: