Device Development & Testing Engineer – Drug Delivery / Combination Products (Lab, Failure Anal[...]

3key Consulting, Inc.; Thousand Oaks (CA); On-site; USD 75,000 - 85,000; Full time

Job summary

A consulting firm in drug delivery is seeking a Device Development & Testing Engineer in Thousand Oaks, CA. This hybrid role demands strong laboratory testing experience with combination products and medical devices. Key responsibilities include conducting experimental testing, refining test procedures, and collaborating with teams. Candidates should possess a relevant degree and a solid background in failure analysis. Join a dynamic environment dedicated to advancing drug delivery devices.

Qualifications

• Strong laboratory testing experience, particularly with combination products and medical devices.
• Familiarity with regulatory and quality requirements for combination products and medical devices.

Responsibilities

• Conduct hands-on experimental testing to support failure investigations and root cause analysis.
• Develop, execute, and refine test procedures to evaluate device performance.
• Analyze test data and apply statistical methods.

Skills

Problem solving

Organization

Communication

Education

Master's degree or Bachelor's degree with 2 years experience or Associate degree with 6 years experience or High school diploma/GED with 8 years experience

Job description

Device Development & Testing Engineer – Drug Delivery / Combination Products

Location: Thousand Oaks, CA. 91320 - Hybrid

Employment Type: Contract

Pay Rate: $36 - $41/hour W2

Job Description

Our ideal candidate will have strong laboratory testing experience, particularly with combination products and medical devices, a solid foundation in experimental methods and data analysis, proficiency in statistical tools and methodologies, experience in failure analysis and implementing design solutions, ability to collaborate in cross‑functional teams, strong organizational skills and attention to detail with design history files, and 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 our client’s portfolio of drug delivery devices.

Key Responsibilities

• Conduct hands‑on experimental testing to support failure investigations and root cause analysis.
• Develop, execute, and refine test procedures to evaluate device performance and functionality.
• Analyze test data and apply statistical methods to derive actionable insights and recommendations.
• Support design changes by leading testing efforts to assess and validate proposed modifications.
• Participate in scale‑up, global launch, and continuous improvement of drug delivery devices.
• Collaborate with contract manufacturers and suppliers to ensure device quality and performance standards.
• Maintain robust design history files for mechanical and electro‑mechanical delivery devices.
• Enhance and expand delivery device platform to meet evolving product and regulatory requirements.

Top Must Have Skills

• Problem solving (engineering skillset)
• Organization (self‑starter and project level management)
• Communication (experience communicating at different levels and to different groups)
• Nice to have: 1‑2 years of experience

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 (21CFR820) and Risk Management (ISO 14971).

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