Engineer, Drug Device Combination Product – Prefilled Syringes / Hybrid (JP13580)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Drug Device Combination Product – Prefilled
Syringes / Hybrid (JP13580) Location: Thousand Oaks, Ca. Business
Unit: Prefilled Syringes And Lyo Kit Platforms Employment Type:
Contract Duration: 12 months with likely extensions or conversion
to perm Rate : $36-41/hours W2 with benefits Posting Date:
1/28/2025 Target Start Date: 2/3/2025 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 the company’s
combination product portfolio. Essential skills and
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 company’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 the company’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: 1. Degree in the
field of Mechanical or Biomedical. 2. Medical device industry
and/or regulated work environment experience. 3. Excellent written
and verbal communication skill. 4. 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 Additional stand-alone red flag: inability to be present
on site/support onsite based activities. This is a hybrid role, NOT
fully remote. 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
recruiting@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, Cerritos , Engineer, Drug Device Combination Product – Prefilled Syringes / Hybrid (JP13580), Engineering , Thousand Oaks, California
