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?:

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