Senior Systems Engineer, Medical Device Technical Lead (JP11791)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Senior Systems Engineer, Medical Device Technical
Lead (JP11791) Location: Thousand Oaks, CA. Business Unit: Final
Product Technical Leads Employment Type: Contract Duration: 18
Months with possible extensions or conversion to FTE Rate : $46 -
$51/hour W2 Posting Date: 09/19/2023 Notes: Qualified candidates
with either a strong Electrical Engineering, Mechanical
Engineering, OR Systems/Software Engineering background need apply
and will be considered. Candidates must elaborate on their
experience in Excel macros and product development on their resume.
3 Key Consulting is recruiting a Senior Systems E ngineer, Medical
Device Technical Lead for a consulting engagement with our direct
client, a leading global biotechnology company. Job Description:
Candidates must have experience in the biotechnology,
pharmaceutical, or medical device industry. Candidates must have at
least 5 years’ experience in systems engineering. Candidates must
have great communication skills and can lead meetings and work
teams. Candidates must have strong background in documenting
requirements and providing traceability documentation for FDA
approval DOORS Requisite Pro, or other similar requirements
management software. Practical experience in configuration
management and change control process/requirements, CCB (change
control board), CIT (change implementation team) concepts
experience is preferred. The Systems Engineer (SE) works as part of
cross-functional program teams to deliver technical content,
performance, intellectual property and quality deliverables of a
combination product development program. The Systems Engineer
understands and captures the user needs into system requirements
and participates in the functional decomposition and allocation to
subsystems. The Systems Engineer ensures that the quality targets
are satisfied, identifies technical risks and assists risk
retirement activities on the program. The Systems Engineer
maintains close interaction with customers to understand and
enhance the ability to deliver on customer satisfaction through
high product quality. Top Must Have Skill Sets: Systems Engineering
past work experience. Ability to communicate effectively and lead
large teams in development of technical deliverables required for
design control deliverables. Past experience in writing SOPs,
Guidance & technical documents is preferred but not required
Proficient in Microsoft Excel especially in writing macros in
excel. Day to Day Responsibilities: 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 requirements documents, design documents,
specifications, development plans, characterization plan,
verification and validation plans and other related product
development documents for assigned projects. Responsible for
writing technical and guidance documents that provides guidance to
team members in following design control and business processes
within client. Develop Toolsets using Microsoft excel to enable
easier on boarding of other engineers onto client processes Work
and Lead cross functional teams in development of common practices
and write technical guidance documents to enable consistency across
various combination product teams. Basic Qualifications: BS in
Engineering and previous experience in a medical device industry.
10 years current experience with engineering processes and
procedures. Preferred Qualifications: 6 years of progressive
experience as an engineer or scientist within the appropriate field
of study (Systems Engineering) Creative problem solver and solution
developer when presented with conflicting requirements, business
demands and technical risks/issues. Experience in combination
product development. Why is the Position Open? Planned Project. Red
Flags: No degree No systems engineering experience Interview
Process: Video Conference with Hiring Manager. Selected candidates
would then have a panel 1:1 video conference with additional team
members. Candidate must be comfortable with video (webcam) online
interview process. 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, Camarillo , Senior Systems Engineer, Medical Device Technical Lead (JP11791), Engineering , Thousand Oaks, California
