Engineer, Medical Devices (JP12014)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Engineer, Medical Devices (JP12014) Location:
Thousand Oaks, CA. 91320 Business Unit: PFS And Lyo Kit Platforms
Employment Type: Contract Duration: 1 years with possible
extensions or conversion to FTE Rate : $37 - $41/hour W2 Posting
Date: 11/29/2023 Notes: ONSITE - candidate is expected to be in
mechanical lab and support. 3 Key Consulting is recruiting an
Engineer for a consulting engagement with our direct client, a
leading global biotechnology company. Ideal Candidate : Force
testing, good documentation and lab safety, technical writing,
electronic data, Data verification i.e. what goes into reviewing
technical documentation. Familiarity with Minitab and JMP. basic
statistics, ANOVA and capability experience. Bachelor Degree and 2
years of experience. working in a mechanical lab. Familiarity with
combination product development. Familiarity with design controls.
specifically prefilled syringes. Job Description: The Device
Engineer will participate in the design, development, and lifecycle
management design control activities for commercialized drug
delivery devices. This role includes technical operations support
for combination product development to global launch, clinical and
commercial manufacturing, failure investigation, design change
evaluation, development and execution of test procedures, and
continuous improvement initiatives. Scope includes mechanical
delivery devices, such as Prefilled syringes. The qualified
candidate will be part of a sustaining device engineering team that
ensures design history files of these mechanical delivery devices
are maintained. The engineer will participate in cross functional
teams, leading device design activities such as the development of
product enhancements, analytical failure analysis and
implementation of design solutions, assessment of proposed changes,
support product launches, and defend inspection and ensure the
follow through of commitments. Essential skills and
Responsibilities: Adheres to strict documentation practices in a
GMP regulated environment Fully competent engineer in all
conventional aspects of the subject matter, functional area, and
assignments, plans and conduct work requiring judgment in the
independent evaluation, selection, and substantial adaptation and
modification of standard techniques, procedures and criteria and
devises new approaches to problems encountered. Authors and reviews
technical documentation including protocols, reports, and technical
assessments Analyze and trend generated data by applying relevant
statistical techniques to enable senior staff to make informed
decisions Coordinates and executes laboratory testing to support
characterization, verification, design transfer, and fill-finish
efforts Maintains combination product design history files for
assigned products Develops characterization test methods through
fixture prototyping, reference sample creation, and GR&R
analysis Provides functional subject matter expertise to actively
participate in cross-functional activities including system level
root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management,
sample shipments, and cleanup. Works with Scientists and Engineers,
to assess and develop appropriate design and manufacturing
specifications Individual contributor with Leadership attributes to
effectively represent device engineer within a large network/matrix
organization At a minimum familiar with the following standards and
regulations: Quality System Regulation – 21CFR820 Risk Management –
ISO 14971 EU Medical Device requirements – Council Directive
93/42/EEC Basic Qualifications: Master degree OR Bachelor degree
and 2 years of experience OR Associate degree and 6 years of
experience Preferred Qualifications: Bachelor’s Degree or higher in
relevant engineering or scientific field (Mechanical, Biomedical,
Bioengineering) Minimum 1 year of scientific or engineering
experience in a GxP regulated environment Statistical Analysis
software (Minitab or JMP) Strong technical writing skills CAD
fixturing software (SolidWorks) Instron force tester using BlueHill
Universal Experience with design controls; including (but not
limited to) verification and design transfer Understanding of risk
assessments including hazard and probability analysis Background in
medical device development, commercialization, and knowledge of
manufacturing processes (fill-finish) Ability to work independently
and dynamically across functional team Excellent written and verbal
communication skills Ability to support complex workstreams under
demanding timelines. Top Must Have Skill Sets: Hands on Laboratory
Experience in a GxP Setting (Science or Engineering Lab) Good
Communication and Technical Writing Skills Data Analysis and
Problem Solving Day to Day Responsibilities: The device engineer
will support a senior engineer on a variety of projects related to
laboratory testing, life cycle management, and product-based
initiatives regarding prefilled syringes in both the commercial and
developmental space. The engineer will be expected to author
protocols, reports, and further technical documentation while
adhering to GMP standards. Laboratory testing will primarily
include the use of an Instron force tester and vision systems. The
identified candidate must be able to lift up to 50 lbs for receipt
and transferring of material. Fill-Finish experience is a bonus but
not mandatory. The engineer will be evaluated on ability to
complete a wide variety of supporting tasks for projects in a
timely manner while maintaining a high standard of quality.
Employee Value Proposition: great opportunity for growth in career
Why is the Position Open? Supplement additional workload on team.
Red Flags: No previous industry or laboratory experience Unfamiliar
with Good Documentation Practices Interview Process: 2-3 rounds of
interviews. Individual Interviews (x2) - WebEx or In-person Panel
Interview (x1) – WebEx 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, Anaheim , Engineer, Medical Devices (JP12014), Engineering , Thousand Oaks, California
