Job Title : Engineer - Design, Development, Lifecycle Management Drug Delivery Devices

Job Title : Engineer - Design, Development, Lifecycle ManagementDrug Delivery Devices - (JP13249)

Location : Thousand Oaks, CA. 91320 (Hybrid)

Business Unit :

Employment Type : Contract

Duration : 1+ year with likely extensions and / or conversion to a permanent position.

Rate : $38 - $42 / hour W2

Posting Date : 12 / 19 / 2024.

Notes : Only qualified candidates need apply.

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

Job Description :

The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of clients's combination product portfolio.

Key responsibilities include :

• Conducting hands-on experimental testing to support failure investigations and root cause analysis.
• Developing, executing, and refining test procedures to evaluate device performance and functionality.
• Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
• Supporting design changes by leading testing efforts to assess and validate proposed modifications.
• Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
• Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
• Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
• Enhancing and expanding client's delivery device platform as needed to meet evolving product and regulatory requirements.

The ideal candidate will :

Top Must Have Skill Sets :

Day to Day Responsibilities :

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

Red Flags :

Missing two or more of the following four items :

o -Development / commercialization of medical devices and knowledge of manufacturing processes

o -Initiating and bringing complex projects to conclusion

o -Ability to work independently and dynamic cross functional teams

o -Design controls

o -Failure investigation

o -Applied statistics

Additional stand-alone red flag : inability to be present on site / support ATO-site based activities. This is a hybrid role, NOT fully remote.

Why is the Position Open?

Planned Project

Interview Process :

Screening interview with myself, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.

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

Regards,

3KC Talent Acquisition Team