Engineer, Biomedical/Medical Device - (JP11347)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Biomedical/Medical Device - (JP11347)
Location: Thousand Oaks, CA. 91320 Business Unit: Systems
Engineering Employment Type: 1 year c ontract to hire. Posting
Date: 03/13/2023 Notes: Only qualified candidates need apply. Job
requires on-site attendance. Shift/Schedule: Monday - Friday, 8am -
5pm (ATO). 3 Key Consulting is recruiting an Engineer for a
consulting engagement with our direct client, a leading global
biopharmaceutical company. Job Description: The Device Engineer
will participate in the medical device/combination product design,
development, and commercialization activities for drug delivery
devices, focusing on prefilled syringes. Top Must Have Skill Sets:
Hands on Laboratory Experience in a GLP Setting- 1 years of
experience. Good Communication and Technical Writing Skills Ability
to Multitask Must have BS degree Mechanical or Biomedical
Engineering, or related field. Day to Day Responsibilities: Test
procedure development and functional test execution Authoring
technical plans and reports Performing statistical data analysis
Supporting technical assessments and root cause investigations
Transfer of information to manufacturing sites, engagement with
suppliers Maintenance of Design History File content consistent
with Good Documentation Practices Basic Qualifications: Fully
competent engineer in all conventional aspects of the subject
matter, functional area, and assignments. Plans and conducts work
requiring judgment in the independent evaluation, selection, and
adaptation and modification of standard
techniques/procedures/criteria, and devises new approaches to
encountered challenges. Generates and maintains design
specifications, protocol and report writing, prototyping, design of
experiments/statistical process control product optimization,
design verification & validation, FMEA, etc. System level root
cause investigation; CAD/SolidWorks proficiency; tolerance
analysis; capability analysis. Coordinate and implement design
improvements with development partners. Collaborate with scientists
and engineers internally and externally to assess and develop
appropriate design and manufacturing specifications. Accountability
of maintaining technical records within product design history
files. Individual contributor with leadership attributes to
effectively represent device engineering within a large
network/matrix organization. Working proficiency and familiarity
with governing standards and regulations, including Quality System
Regulation (21CFR820) and Risk Management (ISO 14971). Preferred
Qualifications: Degree in the field of Mechanical or Biomedical
Engineering, or related field Medical device industry and/or
regulated work environment experience Excellent written and verbal
communication skill Understanding and experience in:
Development/commercialization of medical devices and knowledge of
manufacturing processes Initiating and bringing complex projects to
conclusion Ability to work independently and dynamic cross
functional teams Design controls Failure investigation Applied
statistics Red Flags: No laboratory experience or desire to work in
a lab environment (not considering less than a year) No desire to
work in cross-functional team environment Poor communication and
technical writing skills Many positions in a short time frame (e.g.
3 per year) Interested in remote-only; this job requires on-site
attendance 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, Anaheim , Engineer, Biomedical/Medical Device - (JP11347), Engineering , Thousand Oaks, California
