Engineer Senior, Drug Delivery Medical Device - (JP9675)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer Senior, Drug Delivery Medical Device -
(JP9675) Location: Thousand Oaks, CA. Employment Type: Contract
Business Unit: Mechanical Autoinjectors Platform Duration: 1 years
(with likely extensions and/or conversion to permanent) Posting
Date: 1/13/2022 Notes: 3 Key Consulting is hiring an Engineer
Senior for a consulting engagement with our direct client, a
leading global biopharmaceutical company. Job Description: Support
the 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, and micro-infuser delivery pump systems. The qualified
candidate will support technical teams to ensure successful device
development of these mechanical and electro-mechanical medical
devices. The Sr. Engineer will work closely with device Subject
Matter Expert (SME) to support develop detailed engineering
specifications, device design & development, support verification,
validation, and regulatory submissions of these devices. The role
of the Sr. 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
Quality, Operations, and Development. Create and assess product
requirements to determine technical coverage and proper integration
different subsystems. 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 technical
assistance for junior engineers. Why is the Position Open?
Supplement additional workload on team Top Must Have Skills: 1. 5
years min experience in device engineering end to end configuration
control management 2. Design characterization, verification
execution. 3. Device design experience(design for six sigma
experience a ) Day to Day Responsibilities: Support and manage day
to day commercial advancement operation to ensure deliverables and
deadlines are met. Coordinate activities and provide guidance to
jr. engineers Basic Qualifications: BS in Engineering and previous
experience in a medical device industry. 10 years current
experience with engineering processes and procedures. 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). Experience in drug/device
combination product design and development. Familiar with the
following standards: Quality System Regulation 21CFR820 - Risk
Management; ISO 14971 - EU Medical Device requirements; Council
Directive 93/42/EEC - Medical Electrical Equipment; EN 60601 -
Small scale device assembly experience. Ability to read, analyze,
and interpret general 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. VERY IMPORTANT NOTE: Qualified
candidates with either a strong Electrical Engineering, Mechanical
Engineering, OR Systems Engineering background need apply and will
be considered Employee Value Proposition: Great biotech/pharma to
work for. Red Flags: Applicants without 5 years of experience with
one company. Interview process: Video Skype 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, La Habra , Engineer Senior, Drug Delivery Medical Device - (JP9675), Engineering , Thousand Oaks, California
