Engineer, Drug Delivery Devices Testing & Analysis (JP13861)

Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026

Job Description:

Job Title: Engineer, Drug Delivery Devices Testing & Analysis (JP13861) Location: Thousand Oaks, CA. 91320 (Hybrid) Business Unit: Pre-filled Syringes & Kit Platform Employment Type: Contract Duration: 1 year with likely extensions and/or conversion to a permanent position. Rate: $38 - $42/hour W2 Posting Date: 03/18/2025. Notes: Only qualified candidates need apply. The candidate will need to have availability to go onsite any day of the week, M-F. Hybrid schedule will be 3-4 days per week for the first 2 quarters and then determined depending on business needs. 3 Key Consulting is hiring! We are recruiting an Engineer, Drug Delivery Devices 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 client’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 (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 Red Flags: Missing two or more of the following four items: • 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: 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, 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

Keywords: 3 Key Consulting, Fountain Valley , Engineer, Drug Delivery Devices Testing & Analysis (JP13861), Engineering , Thousand Oaks, California