Engineer, Medical Combination Devices; JP

Position: Engineer, Medical Combination Devices (JP11898)
Job Title: Engineer, Medical Combination Devices (JP11898)
Location: Thousand Oaks, CA. 91320
Business Unit: Combination Product Development
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate
: $38 - $42/hour W2
Posting Date:10/31/2023
Notes: Only qualified candidates need apply. Local candidates only. Should be standard hours Monday to Friday
in Office to support Denmark 2 times a week may be expected to be on call at 6 am. can be done remote, but would come to site after call.

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:

Note:

Not interested in remote only candidates. Should be standard hours Monday to Friday in Office to support Denmark 2 times a week may be expected to be on call at 6 AM PST. Can be done remote, but would come to site after call. Time on campus will be lab work and will be working with lab equipment. There is hybrid opportunity once candidate is seen to be self-sufficient.

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

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 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.

Day to Day Responsibilities:

• (50%) 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)
• (30%) 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
• (20%) Statistical data analysis of test results to be included in technical reports.

Basic Qualifications:

• Master’s degree OR
• Bachelor’s degree and 2 years of experience…