Engineer, Medical Combination Devices (JP11898)

3 Key Consulting•Thousand Oaks, CA

6d•Hybrid

About The Position

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company. This role is for the Combination Product Test Team and involves the development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. The position requires a strong proficiency in developing test protocols, statistical analysis, executing hands-on testing, and reporting results. The candidate will work with experienced Device Test Engineers, authoring test protocols, executing test plans, performing data analysis, and finalizing test reports. The role involves supporting senior staff in project milestones for verification testing activities. The chosen candidate will frequently spend time in a lab environment working with various testing equipment, from manual measuring equipment to fully automated testing systems. The devices 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 share best practices, discuss issues and resolutions, and create a testing strategy. The chosen candidate may also take part in the design and fabrication of test fixtures and processes. The position is open to supplement additional workload on the team.

Requirements

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
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.

Nice To Haves

Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.

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.
Employing engineering skills and practices to gather user requirements and translate 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.
Technical authorship of test protocols and reports to support characterization and verification activities.
Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control).
Hands-on execution of test protocols in a lab environment, operating test equipment to collect data and record data according to good documentation practices.
Testing of autoinjector devices, including the safe operation of test equipment.
Statistical data analysis of test results to be included in technical reports.