Engineer Senior, Drug Delivery Medical Device (JP9612)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
|
|
|
Job Description:
Job Title: Engineer Senior, Drug Delivery Medical Device
(JP9612) Location: Thousand Oaks, CA. Employment Type: Contract
Business Unit: FPT Development Product Engineering Duration: 1
years (with likely extensions and/or conversion to permanent)
Posting Date: 1/3/2022 3 Key Consulting is hiring a Senior Engineer
for a consulting engagement with our direct client, a leading
global biopharmaceutical 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, and 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. Why is the
Position Open? Planned project. Top Must Have Skills: Design
controls. Mechanical testing. Drug delivery experience. Risk base
process. Presentation skills. Day to Day Responsibilities: Author
device documentation to support development, planning,
verification, validation, and transfer. Author test protocols and
execute mechanical testing of drug delivery devices. Presentation
and communication skills (within program teams). Execute and
deliver within regulated development processes. Proactively
maintains close communication with technical leads. Basic
Qualifications: BS in Engineering and previous experience in a
medical device 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: 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
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. MERY
IMPORTANT NOTE: Qualified candidates with either a strong
Electrical Engineering, Mechanical Engineering, OR Systems/Software
Engineering background need apply and will be considered Red Flags:
Less than 5 years of experience. Jumpy job history. Lack of
enthusiasm and not self-motivated. 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, Rancho Santa Margarita , Engineer Senior, Drug Delivery Medical Device (JP9612), Engineering , Thousand Oaks, California
