Engineer Senior, Drug Delivery Devices/Development & Commercialization (JP13860)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer Senior, Drug Delivery Devices/Development &
Commercialization (JP13860) Location: Thousand Oaks, CA. 91320
(Hybrid) Business Unit: Prefilled Syringes & Kit Platform
Employment Type: Contract Duration: 1 year with likely extensions
and/or conversion to a permanent position. Rate: $45 - $50/hour W2
with benefits Posting Date: 05/1/2025. Notes: Only qualified
candidates need apply. Onsite in Thousand Oaks, CA - 2-3 days per
week onsite. 3 Key Consulting is hiring! We are recruiting an
Engineer Senior, Drug Delivery Devices for a consulting engagement
with our direct client, a leading global biotechnology company. Job
Description: The Device Engineer will participate in the medical
device/combination product design, development, and
commercialization activities for drug delivery devices, focusing on
prefilled syringes. The ideal candidate will have a B.S. and a
minimum of 3 strong years of experience. 5 YOE is ideal. Nice to
have: someone who has experience working on prefilled syringes or
vials. Combination product experience. Regulatory experience. Top
Must Have Skill Sets: • Pharma background. • Physical testing
experience • Design controls experience Day to Day
Responsibilities: • Leading test procedure development and
functional test execution • Leading material inventory management
for prefilled syringe programs, including material forecasting and
material custody across multiple sites and functional groups. •
Authoring technical plans and reports • Performing advanced
statistical data analysis • Supporting Leading technical
assessments and root cause investigations as well as planning and
delegation of sub-tasks to other team members. • Transfer of
information to manufacturing sites, engagement with suppliers •
Maintenance of Design History File content consistent with Good
Documentation Practices • Training junior staff on physical test
methods, sample preparation protocols and procedures, and effective
report writing. • Reviewing primary data collected from peers in
support for various design controls activities, including
characterization and design verification. • Supporting design
transfer activities by leading cross-functional coordination of
sample procurement and testing. • Supporting the setting of
specification limits for platform devices through human factors
studies benchtop testing. Essential Skills: • Doctorate degree OR
Master degree and 3 years of experience OR Bachelor degree and 5
years of experience OR Associate degree and 10 years of experience
OR High school diploma / GED and 12 years of experience • 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; CAD/SolidWorks proficiency; tolerance
analysis; capability analysis. • 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). Preferred Qualifications: • Degree in the field of
Mechanical or Biomedical Engineering, or related field • Medical
device industry and/or regulated work environment experience •
Excellent written and verbal communication skills • 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 Red Flags: • Poor
communication skills • Lack of hands on testing experience Why is
the Position Open? Planned Project Interview Process: One round of
interviews. 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, Yorba Linda , Engineer Senior, Drug Delivery Devices/Development & Commercialization (JP13860), Engineering , Thousand Oaks, California
