Engineer – Design, Development, Lifecycle Management Drug Delivery Devices JP

Position: Job Title: Engineer – Design, Development, Lifecycle Management Drug Delivery Devices - (JP13249)
Job Title: Engineer – Design, Development, Lifecycle Management Drug 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:

• Have strong laboratory testing experience, particularly with combination products and medical devices.

• Possess a solid foundation in experimental methods and data analysis.

• Be proficient in statistical tools and methodologies.

• Demonstrate experience in failure analysis and implementing design solutions.

• Have a proven ability to collaborate effectively within cross-functional teams.

• Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.

• Show familiarity with regulatory and quality requirements for combination products and medical devices.

• This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing client’s portfolio of drug delivery devices.

Top Must Have Skill Sets:
• Problem solving (engineering skillset)

• Organization (self-starter and project level management)

• Communication (experience communicating at different levels and to different groups)

Day to Day Responsibilities:
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.

• Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.

• Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.

• System level root cause investigation

• Coordinate and implement design improvements with development partners.

• Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.

• Accountability of maintaining technical records within product design history files.

• Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.

• Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21

CFR
820) and Risk Management (ISO 14971).

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of…