Engineer, Needle- Injection Systems Mechanical Testing; JP

Position: Engineer, Needle-Based Injection Systems Mechanical Testing (JP13883)
Job Title: Engineer, Needle-Based Injection Systems Mechanical Testing (JP13883)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Design & Development ME
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 03/31/2025.
Notes: Only qualified candidates need apply. Hybrid. Must be local to Thousand Oaks, CA. Minimum 70% onsite after training period. 100% onsite for training in the beginning.

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Key Consulting is hiring! We are recruiting an Engineer - Needle-Based Injection Systems Mechanical Testing - for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application. (ISO 11608-1 Requirements and test methods for needle-based injection systems (NIS) for medical use. These systems are commonly used for the delivery of medicinal products, such as insulin pens, auto-injectors, and similar devices).

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 of this position 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 technical writing, reading comprehension, 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.

Top Must Have Skill Sets:

• 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 have:
Background in statistical analysis.

Day to Day Responsibilities:
• (50%) 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
• (35%) 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)
• (15%) Statistical data analysis of test results to be included in technical reports.

Basic Qualifications:

• Master degree OR Bachelor…