Engineer Senior, Medical Device Root Cause Investigations (JP13462)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer Senior, Medical Device Root Cause
Investigations (JP13462) Location: Thousand Oaks, CA. 91320
Business Unit: Mechanical Autoinjectors Platform Employment Type:
Contract Duration: 1 year with likely extensions and/or conversion
to a permanent position. Rate: $44 - $50/hour W2 Posting Date:
1/213/2025. Notes: Only qualified candidates need apply. 80% Onsite
3 Key Consulting is hiring! We are recruiting a Engineer Senior,
Medical Device Root Cause Investigations for a consulting
engagement with our direct client, a leading global biotechnology
company. Job Description: Our ideal candidate will have a B.S. and
5 YOE experience in root cause investigations, change controls,
deviations, and CAPA. Having Minitab and Pharma or med device
background is a plus! 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; • 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. Top Must Have Skill Sets: •
Previous experience in medical devices/pharma • Project management
• Good Documentation Practices Day to Day Responsibilities: Worker
must be able to accomplish given tasks with minimal supervision.
Expectation is that worker will lead projects to completion and
work cross functionally to overcome any technical hurdles. • 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. Basic
Qualifications: • Doctorate degree OR Master degree and 3 years of
experience OR Bachelor degree and 5 years of experience OR
Associate degree and 10 years of experience OR High school diploma
/ GED and 12 years of experience • BS in Engineering and previous
experience in a medical device industry • 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) 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 • 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. Red
Flags: No engineering degree/experience Why is the Position Open?
Supplement to the team Interview Process: 1 phone interview and 1
video call 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, Lake Forest , Engineer Senior, Medical Device Root Cause Investigations (JP13462), Engineering , Thousand Oaks, California
