Engineer Senior, Drug Delivery Devices (JP11638)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
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Job Description:
Job Title: Engineer Senior, Drug Delivery Devices (JP11638)
Location: Louisville, KY. 40201 Business Unit: Logistics and
Transportation. Employment Type: Contract Duration: 1 years (with
possible extensions) Rate : $46 - $51hour W2 Posting Date:
06/01/2023 Notes: Only Qualified candidates with either a strong
Electrical Engineering, Mechanical Engineering, OR Systems/Software
Engineering background need apply and will be considered. 3 Key
Consulting is recruiting an Engineer Senior, Drug Delivery Devices
for a consulting engagement with our direct client, a leading
global biotechnology company. Job Description: Lead teams in the
development of drug delivery devices. Scope includes a wide range
of devices, such as: Needle protection systems Fluid transfer
devices Pen injectors Automatic pen injectors Micro-infuser
delivery pump systems. The qualified candidate will lead technical
teams to ensure successful device development of these mechanical
and electro-mechanical medical devices. The Senior Engineer will
work closely with team members to develop detailed engineering
specifications, device design & development, support verification,
validation, and regulatory submissions of these devices. The role
of the Senior Engineer is to work within a cross-functional
organization to utilize technologies and methodologies that support
short-cycle robust device development. Responsibilities include:
Work cross-functionally with individuals and project teams in
Marketing, Operations, and Development Create and assess product
requirements to determine technical coverage and proper integration
different subsystems. Create and execute to project plans and
schedules Develop, execute, and review architecture documents,
design documents, specifications, development plans,
characterization plan, verification and validation plans and other
related product development documents for assigned projects.
Provide deep technical assistance for junior engineers. Top Must
Have Skill Sets: Systems/Software Engineering background Strong
problem solving, risk assessment, and risk management skills.
Create and execute to project plans and schedules Qualified
candidates with either a strong Electrical Engineering, Mechanical
Engineering, OR Systems/Software Engineering background need apply
and will be considered Day to Day Responsibilities: Third Party
Supplier management Inventory analysis and management Analytical
reporting and data collection Basic Qualifications: BS in
Engineering and previous experience in a medical device industry,
supply chain and QA in a medical industry. 10 years current
experience with engineering processes and procedures. Led projects
from development through the 510k and PMA approval process. Strong
background in engineering and commercialization of
electro-mechanical medical devices. Experience with material & test
specs generation, protocol & report writing, process & test
development, prototyping, design verification, DOE/SPC process
optimization & validation (IQ, OQ, PQ), FMEA. - Product
design/development (design control) from concept to post product
launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in drug/device combination product design and
development Familiar with the following standards: o Quality System
Regulation 21CFR820 o Risk Management ISO 14971 o EU Medical Device
requirements Council Directive 93/42/EEC o Medical Electrical
Equipment EN 60601 Small scale device assembly experience. Ability
to read, analyze, and interpret general business periodicals,
professional journals, technical procedures, or governmental
regulations. Strong problem solving, risk assessment, and risk
management skills. Must be capable of working on multiple projects
in a deadline driven environment. Why is the Position Open?
Supplement additional workload on team Red Flags: Excessive changes
in employers over short span (1-2 years) Candidates that are too
green to engineering. Needs more than education background.
Interview Process: Phone Interview followed by WebEx meeting/panel
interview 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, Malibu , Engineer Senior, Drug Delivery Devices (JP11638), Engineering , Thousand Oaks, California
