Engineer, Electromechanical Medical Device - Hybrid (JP13404)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
|
|
|
Job Description:
Job Title: Engineer, Electromechanical Medical Device - Hybrid
(JP13404) Location: Thousand Oaks, Ca. (2-3 times/month onsite)
Business Unit: Electromechanical Platform Employment Type: Contract
Duration: 3 years with likely conversion to perm Rate :
$36-41/hours W2 with benefits Posting Date: 11/21/2024 Target Start
Date: 01/13/2025 3 Key Consulting is hiring! We are recruiting an
Engineer for a consulting engagement with our direct client, a
leading global biotechnology company. Ideal Candidate :
Self-sufficient, team-oriented candidate with strong communication
and technical documentation skills. Ideal candidates should have
electromechanical or engineering experience, proficiency in
complaint management systems, and knowledge of CAPA processes and
GDP. Familiarity with Excel for data analysis. Stability and a
bachelor’s degree with a few years of relevant experience are
preferred. Medical device industry experience and regulated work
environment experience. Strong understanding and experience in
design controls, failure investigation (leading an investigation)
Job Description: Perform Sustaining Engineering activities of
combination products with electromechanical delivery systems. Such
activities support the identification, review, assessment, and
resolution of deficiencies throughout the product’s life cycle.
Responsible for product life cycle change management and ensures
design controls are documented in accordance with internal
procedures. Support multi-functional assessment of complaint
records Top Must Have Skill Sets: Ability to clearly communicate
with diverse teams, including Engineering, Manufacturing,
Regulatory, and Quality colleagues. Strong written skills for
documenting changes, updates to risk files, and communication with
leadership. Multidisciplinary assessment of complaints and
problem-solving. Day to Day Responsibilities: Complete product and
manufacturing process changes, including documentation and risk
file updates to ensure there is no adverse impact to the
patient/user and product design integrity is maintained Implement
change projects according to internal procedures, supervise
progress, and communicate status to group leadership Communicate
with Engineering, Manufacturing, Regulatory, and Quality colleagues
Establish experimental protocols, conduct experiments, analyze
results Support technical execution of Design History File (DHF)
updates Establish and maintain relationships with manufacturing
site colleagues Support Manufacturing and Quality Assurance in the
disposition of Non-Conforming Reports and the qualification of
material/processes changes Establish and review
specifications/requirements for components, products and processes
Support CAPA investigations Ensures product conforms to current
relevant international standards Support multi-functional
assessment of complaint record Basic Qualifications: Master degree
OR Bachelor degree and 2 years of experience OR Associate degree
and 6 years of experience OR High school diploma / GED and 8 years
of experience Red Flags: Difficulty clearly communicating with
cross-functional teams or documenting changes effectively. Lack of
precision or detail in written documentation Inability to convey
project progress or results to leadership, leading to
misunderstandings or misalignment Interview Process: Screening
interview with the hiring manager followed by team interview. We
invite qualified candidates to send your resume to
recruiting@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, Fullerton , Engineer, Electromechanical Medical Device - Hybrid (JP13404), Engineering , Thousand Oaks, California
