Engineer Principal, Medical Device - Physical Test Methods (JP11208)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer Principal, Medical Device - Physical Test
Methods (JP11208) Location: Thousand Oaks, CA. 91320 Employment
Type: Contract Business Unit: Physical Testing Systems Development
Duration: 18 months with likely extensions and/or conversion to
permanent Posting Date: 01/03/2023 Notes : Onsite - Shift/Schedule:
Monday - Friday, 7:00am – 4:00pm, 8:00am - 6:00pm (flexible) 3 Key
Consulting is hiring an Engineer Principal for a consulting
engagement with our direct client, a leading global
biopharmaceutical company. Job Description: Reporting to the
Director Physical Sciences and Engineering, Manufacturing Sciences
and Technology (MSAT), the successful candidate for this position
will manage (projects, personnel, and laboratory) an engineering
group responsible for development of innovative solutions to
complex biotechnology device and packaging problems based on
insightful interpretation and analysis of the problem statement or
investigation. These key activities serve MSAT in the development
of physical methods, characterization studies, and design
verification deliverables for CPO. The principal engineer will
operate in a highly matrixed environment to collaborate effectively
with cross functional teams. The principal engineer is responsible
to critically analyze department requirements, ensure documentation
and laboratories maintain proper state of qualification,
calibration and preparedness for inspections related to safety,
compliance and procedures. The principal engineer must also clearly
communicate and elevate technical or strategic issues to team
members and management as needed and make robust recommendations
and/or decisions to guide successful execution of mechanical
testing for primary containers, device and packaging test methods.
Group members within the functional area look up to this position
as a scientific/technical expert who can provide guidance on
associated issues as needed. Demonstrated supervisory skillare
required. Responsibilities : Own and maintain business processes
for development, qualification, validation and transfer of physical
test methods for product verification of new products, and transfer
of validated methods to company supply chain, Quality, or
manufacturing labs at all company sites. The principal engineer
must ensure documentation can withstand an audit and pass agency
scrutiny. Develop and own Standard Operating Procedures for data
creation, storage, retention, and audit in accordance with Title 21
CFR Part 11 Compliance for all lab testing and associated 21CFR 820
requirements for device development. Rapidly design, develop,
qualify, and innovate automated inspection equipment for company
primary containers and devices to meet new and unique product
requirements. Work with Device Technologies to advance state of the
art physical methods and other emerging technologies to
characterize, evaluate, and release combination products, primary
containers, and secondary packaging. The candidate is expected to
support input data solutions going into Device Master Records and
associated work product with clinical and commercial manufacturing
for combination products, primary containers, and secondary
packaging. Design, develop and execute mechanical testing using
phase appropriate controls for the development and qualification of
primary container platforms and medical devices to develop
specifications. Facilitate communication with compay sites and
vendors to establish user requirements for the characterization of
primary packaging components used in the commercialization of drug
products and devices Work closely with facilities, maintenance,
instrumentation, and electrical systems to ensure laboratory
equipment is maintained in compliance with all industry,
regulatory, corporate, and regulatory standards. Ensure laboratory
compliance for quality audits utilizing internal and external
calibration laboratories, vendors and suppliers. Advise others on
methods of resolving measurement problems. Keep current with
information from other industry experts through participation in
government and industrial standardization committees and
professional societies Basic Qualification Doctorate degree and 2
years of engineering experience OR Master’s degree and 6 years of
engineering experience OR Bachelor’s degree and 8 years of
engineering experience. 2 years of managerial experience directly
managing people and/or leadership experience leading teams,
projects, programs or directing the allocation of resources
Preferred Qualifications: Degree in Engineering, MBA or related
field 8 years of experience with 3 years’ experience in leading a
highly matrixed physical characterization metrology laboratory in a
highly regulated environment Experience including managing a lean,
high performing technical staff for 3 years, direct experience in
optimization of equipment designs, physical methods, statistical
design (Six sigma is highly desired), geometric dimensions and
tolerances, kinetic modeling, Solid Works engineering drawing, DOE,
and DFM tool sets Formal education in project management Excellent
problem solving, trouble shooting, and communication skills.
Ability to participate in global cross-functional teams and work
effectively in a highly matrixed team environment with rapidly
evolving challenges Demonstrated competencies skills and proven
track record of leading cross-functional projects, ability to coach
junior engineers, strong team work, excellent interpersonal and
communication skills Experience with MS Office Suite, MS
SharePoint, MS Project, Minitab/JMP, SolidWorks Top Must Have
Skills: Test Method development/validation experience, Equipment
qualification and implementation Experience with regulated industry
Pharma, Biotech, preferred Experience with managing projects and
teams Masters, PhD degree, Bachelors with minimum 8 years Day to
Day Responsibilities: Own and maintain business processes for
development, qualification, validation and transfer of physical
test methods for product verification of new products, and transfer
of validated methods to company supply chain, Quality, or
manufacturing labs at all client sites. The principal engineer must
ensure documentation can withstand an audit and pass agency
scrutiny. Red Flags: No formal engineering training No BS degree
Job jumping - multiple job changes within the year Interview
process: Phone screen - 30 min Panel interview via Webex. We invite
qualified candidates to send your resume to
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to take a
look at the other positions on our website
www.3keyconsulting.com/careers. You are welcome to also share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Glendora , Engineer Principal, Medical Device - Physical Test Methods (JP11208), Engineering , Thousand Oaks, California
