Engineer Needle-Based Injection Systems Mechanical Testing JP13883

Job Title: Engineer NeedleBased 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.


3Key Consulting is hiring! We are recruiting an Engineer NeedleBased 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 116081 and their application. (ISO 116081 Requirements and test methods for needlebased injection systems (NIS) for medical use. These systems are commonly used for the delivery of medicinal products such as insulin pens autoinjectors and similar devices).

The Mechanical Engineer on the Combination Product Test Team will interact with global and crossfunctional 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 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 116081 and their application.
Nice to have: Background in statistical analysis.

Day to Day Responsibilities:
50 Hands on 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 testlab equipment/process/control)
15 Statistical data analysis of test results to be included in technical reports.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications:

Red Flags:
Candidates with Software or Electrical engineering these are NOT desired for the role.
No lab experience
Different industry (no experience of med device)
No mechanical or med device.
Spelling and grammatical errors in resume. Frequent short job durations and job hopping.

Why is the Position Open
Supplement additional workload on team

Interview Process:
There will be between 12 panel interviews then final interview with director.up interviews with Engineering staff. Once narrowed down a final interview with Associate Director of the team.

We invite qualified candidates to send your resume to If you decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our website www.3keyconsulting/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.