Engineer, Combination Device MS&T (JP13077c)
Company: 3 Key Consulting
Location: Cambridge
Posted on: April 2, 2026
|
|
|
Job Description:
Job Title: Engineer, Combination Device MS&T (JP13077c)
Location: Cambridge, MA. 02138 Business Unit: Physical Methods
Development Modelling and Emerging Methods Employment Type:
Contract Duration: 2 years with likely extensions and/or conversion
to hire. Rate : $38 - $42/hour W2 Posting Date: 7/24/2024. Notes:
Only qualified candidates need apply. Can be within commutable
distance of client’s Cambridge, MA. facility. 3 Key Consulting is
hiring! We are recruiting an Engineer, Combination Device MS&T
for a consulting engagement with our direct client, a leading
global biotechnology company. Job Description: Our ideal candidate
will have: 3 YOE in field desired with bachelors. Experience
working in a regulated industry, exposure to GMPs, Medical Device
experience is highly desired. Mathematical background fundamentals
of statistics. Useful to have exposure to test method development,
CAD design, SolidWorks, mechanical modeling. Nice to have
programming R and python experience. hands on technical experience
useful, comfortable working within a lab. Position involves support
of senior staff in the initiation, design, and delivery of
projects, particularly for the Combination Product Operations
MS&T - Physical Sciences and Engineering (PSE) organization.
Responsibilities include development and lifecycle management of
Physical GMP Test Methods, lifecycle management of integrated
testing machines, development and validation of test methods. The
successful candidate employs basic engineering skills and practices
to gather user requirements and translate them into technical
documentation. Assist with project definition by performing
engineering studies and assessment for automated test systems
installations. Perform field evaluations of existing systems and
provide engineering design recommendations. The ideal candidate
enjoys tackling challenges and excels at organizing information
from numerous sources to provide well-constructed deliverables.
This individual has a passion for modeling, analytics, and
technology. The successful candidate will be given opportunities to
apply their expertise to enhance the way data is used to inform and
make decisions This may include, but is not limited to, the
following: Collaborate with Engineers using the system to edit,
develop, and run automated, experimental protocols. Knowledge on
Equipment and Method validation principles, generation of Lifecycle
Documentation such as FAT/SAT, IQ/OQ, equipment characterization
protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute
processes on the integrated platforms and equipment. Developing,
enhancing, automating, and managing test data Network with
manufacturing and quality organizations internal to client.
Ensuring all tasks and responsibilities are performed according to
industry-leading scientific standards & accurately documented per
SOPs Monitoring technological developments in the field &
evaluation of new technologies Top Must Have Skill Sets: Excellent
verbal and written communication skills to communicate project
status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics Ability to
manage multiple, competing priorities simultaneously Day to Day
Responsibilities: Collaborate with Engineers using the system to
edit, develop, and run automated, experimental protocols. Run Gauge
Repeatability and Reproducibility studies Assisting Engineers to
successfully develop, transfer and execute processes on the
integrated platforms and equipment. 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 Preferred Skills: Experience working in a
regulated industry, exposure to GMPs Excellent verbal and written
communication skills to communicate project status and risks
associated with integrated timelines to leadership Statistical
analysis, and knowledge of Gage R&R, Knowledge of Optical
measurement devices, force testers, BLE testing Test method
development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ Preferred Traits: Passion
for proactively identifying opportunities through creative data
analysis and modeling Intellectual curiosity with ability to learn
new concepts/frameworks, algorithms, and technology rapidly as
needs arise Ability to manage multiple, competing priorities
simultaneously, experience with MS Project Why is the Position
Open? Supplement additional workload on team Interview Process:
Phone screen. Panel Interview. 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, Arlington , Engineer, Combination Device MS&T (JP13077c), Engineering , Cambridge, Massachusetts
