Device Development & Testing Engineer – Drug Delivery / Combination Products (Lab, Failure Analysis, Design Controls)- (JP15205

3 Key Consulting•Thousand Oaks, CA

2d•Hybrid

About The Position

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

Requirements

Strong laboratory testing experience, particularly with combination products and medical devices.
Solid foundation in experimental methods and data analysis.
Proficiency in statistical tools and methodologies.
Experience in failure analysis and implementing design solutions.
Proven ability to collaborate effectively within cross-functional teams.
Strong organizational skills and attention to detail, especially in maintaining design history files.
Familiarity with regulatory and quality requirements for combination products and medical devices.
Problem solving (engineering skillset)
Organization (self-starter and project level management)
Communication (experience communicating at different levels and to different groups)
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
Degree in the field of Mechanical or Biomedical.
Medical device industry and/or regulated work environment experience.
Excellent written and verbal communication skill.
Understanding and experience in: -Development/commercialization of medical devices and knowledge of manufacturing processes -Initiating and bringing complex projects to conclusion -Ability to work independently and dynamic cross functional teams -Design controls -Failure investigation -Applied statistics

Nice To Haves

1-2 years of experience

Responsibilities

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 Amgen’s delivery device platform as needed to meet evolving product and regulatory requirements.
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 (21CFR820) and Risk Management (ISO 14971).