Contract Development Engineer

Contract Development Engineer

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