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?:

• BA Science, Engineering

All your information will be kept confidential according to EEO guidelines.