Engineer Senior, Drug Delivery Medical Device (JP9905)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
|
|
|
Job Description:
Job Title: Engineer Senior, Drug Delivery Medical Device
(JP9905) 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: 3/2/2022 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 plans, 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: 5 years min experience in device
engineering end to end configuration control management Design
characterization, verification execution. 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
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to look at
the other positions on our website
https://3kc.catsone.com/careers/2010-General. You are welcome to
also share this opportunity with anyone you think might be
interested in applying for this role. Regards, 3KC Talent
Acquisition Team
Keywords: 3 Key Consulting, Carson , Engineer Senior, Drug Delivery Medical Device (JP9905), Engineering , Thousand Oaks, California
