Job Title: Engineer – Design, Development, Lifecycle Management Drug Delivery Devices - (JP13249)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
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 (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 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
Keywords: 3 Key Consulting, Downey , Job Title: Engineer – Design, Development, Lifecycle Management Drug Delivery Devices - (JP13249), Engineering , Thousand Oaks, California
