Senior Engineer, Biotech Combination Products (JP11782T)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Senior Engineer, Biotech Combination Products
(JP11782T) Location: Thousand Oaks, CA. OR Cambridge, MA. Business
Unit: Pre-filled Syringes and Lyo Kit Platforms Employment Type:
Contract Duration: 18 months (with possible extensions) Rate : $45
- $51/hour W2 Posting Date: 09/13/2023 Notes: Only qualified
candidates need apply. Onsite, with some WFH flexibility. 3 Key
Consulting is recruiting an Senior Engineer, Combination Devices
for a consulting engagement with our direct client, a leading
global biotechnology company. Job Description: Ideal candidate:
Minimum of 1 YOE project managing experience. 5-10 YOE in
Engineering with background in med device, biotech, (Aero and Auto
would also be considered). Bachelors or Masters Preferred.
Preferred systems experience: Solid works, CAD, Smartsheet' Lead
and support the Prefilled syringe combination product platform team
in both development and commercial lifecycle of prefilled syringe
(PFS) configurations. Experience leading and managing project
timelines and initiatives while reporting out to management. Scope
includes a the full range of PFS devices and variants, such as;
needle protection systems and different delivery volumes. The
qualified candidate will lead technical teams to ensure successful
device development of these mechanical devices. The Senior Engineer
will work closely with team members acting as a project manager to
develop detailed timelines for ensuring engineering specifications,
device design & development, verification, validation, and
regulatory submissions of these devices are completed on time. Top
Must Have Skill Sets: Project Management Technical understanding of
design controls Device Engineering experience Day to Day
Responsibilities: Supporting platform and product development teams
by acting as a project manager to ensure timelines and delivery
dates are met. Providing technical support and insights to team
members and leading platform initiative projects. - Create and
execute to project plans and schedules; responsible for ensuring
team meets project timelines - 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. -
Support development, execution, and review of 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. Basic Qualifications: -
BS in Engineering and previous experience in a medical device
industry - 5-10 years current experience with engineering processes
and procedures. -Project Management experience - Strong background
in engineering and commercialization of 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 - Experience in drug/device
combination product design and development - Strong problem
solving, risk assessment, and risk management skills - Must be
capable of working on multiple projects in a deadline driven
environment. Preferred Qualifications: Why is the Position Open?
Supplement additional workload on team Red Flags: No Job hopping
Interview Process: Initial Phone screenings and then Webex
interviews with a panel of 3-6 team members. Series of 1:1
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, Inglewood , Senior Engineer, Biotech Combination Products (JP11782T), Engineering , Thousand Oaks, California
