Engineer, Medical Device Test Design and Execution (JP12062)

3 Key Consulting • Thousand Oaks, CA

13d • Hybrid

About The Position

This position is for an Engineer, Medical Device Test Design and Execution for a consulting engagement with a leading global biotechnology company. The Mechanical Engineer on the Combination Product Test Team will interact with global and cross-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, characterization and GMP verification testing and will require a strong proficiency in developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership. This position will work side by side with experienced Device Test Engineers authoring test protocols, executing test plans, performing data analysis, and finalizing test reports. The successful candidate will employ engineering skills and practices to gather user requirements and translate them into technical documentation for test execution and analysis. The position involves support of senior staff in the initiation, design, and delivery of projects milestones to support verification testing activities. The chosen candidate will frequently spend time in a lab environment working with various types of testing equipment from manual measuring equipment through fully automated testing systems. The devices that will be tested include various iterations of handheld autoinjector drug delivery systems. This role will include numerous collaboration sessions with the test team and global team to trade best practices, discuss issues and resolutions, and create a testing strategy. The chosen candidate may also take part in design and fabrication of test fixtures and processes.

Requirements

• Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.
• Experience working independently to execute test procedures and operate lab equipment (such as analytical balance, tensile tester, and other automated test equipment) while documenting results according to good documentation practices.
• Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.
• Master’s degree OR Bachelor’s degree and 2 years of experience OR Associate’s degree and 6 years of experience OR High school diploma / GED and 8 years of experience.

Responsibilities

• Development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts.
• Engineering, characterization and GMP verification testing.
• Developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership.
• Authoring test protocols, executing test plans, performing data analysis, and finalizing test reports.
• Gathering user requirements and translating them into technical documentation for test execution and analysis.
• Support of senior staff in the initiation, design, and delivery of projects milestones to support verification testing activities.
• Spending time in a lab environment working with various types of testing equipment.
• Collaboration sessions with the test team and global team to trade best practices, discuss issues and resolutions, and create a testing strategy.
• Design and fabrication of test fixtures and processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level