Engineer Senior, Combination Device Life Cycle Change Management (JP11969)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer Senior, Combination Device Life Cycle Change
Management (JP11969) Location: Thousand Oaks, Ca. Business Unit:
Final Product Technologies Commercial Advancement Employment Type:
Contract Duration: 1 years with possible extensions or conversion
to FTE Rate : $45 - $50/hour W2 Posting Date: 11/10/2023 Note :
Office-based role supporting virtual teams via Webex and phone. 3
Key Consulting is recruiting an Engineer Senior, Drug Delivery
Medical Devices for a consulting engagement with our direct client,
a leading global biotechnology company. Job Description: In this
vital role you will 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. Office-based role supporting virtual teams via Webex
and phone. Flexibility required when working with global colleagues
in various time zones. Must be able to travel up to 5% - Would be
to Phoeniz AZ if required Key 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 . What we expect of you : We are all
different, yet we all use our unique contributions to serve
patients. The technical professional we seek is a collaborative
partner with these qualifications. 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 Preferred Qualifications Bachelor's degree in
Engineering, Science or other technical degree 1-3 years of
experience with Medical Device or Combination Products Design
Controls, Production, Sustaining Engineering, or Quality role
Proven knowledge and experience in Device Design Control, Risk
Management, Medical Devices, and Combination Products Experience
analyzing patient/user impact Understanding and practical knowledge
of 21 CFR Part 820, ISO 13485 and ISO 14971 and relevant industry
standards Critical thinking, and problem-solving skills An ability
to work independently as well as a member of a team in a fast-paced
environment Working knowledge of statistical methods for data
analysis Familiar with microcontroller-based firmware, software
verification (unit, static, dynamic analysis) Familiar with circuit
design, analysis, troubleshooting, and testing, PCB/PCA assembly
and fabrication Ability to converse technically with mechanical,
electronic, software, clinical, regulatory, and quality engineering
fields The position requires excellent organizational, technical
problem solving and communication skills (written and verbal) and
the ability to lead external teams Top Must Have Skill Sets:
Medical device industry experience and regulated work environment
experience Medical Device Design Controls experience Root cause
analysis experience Why is the Position Open? Supplement additional
workload on team Red Flags: Poor verbal communication skills
Interview Process: Phone Interview followed by WebEx meeting/panel
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, Lake Forest , Engineer Senior, Combination Device Life Cycle Change Management (JP11969), Engineering , Thousand Oaks, California
