Engineer Principal, Drug Delivery Medical Device Process Development - (JP14606)
Company: 3 Key Consulting
Location: New Albany
Posted on: April 2, 2026
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Job Description:
Job Title: Engineer Principal, Drug Delivery Medical Device
Process Development - (JP14606) Location: New Albany, OH. 43054
Employment Type: Contract Business Unit: Site Process development
Duration: 1 years with possible extension or conversion to FTE
Posting Date: 10/10/2025 Pay Rate: $50 - $56/hour W2 with benefits
Notes: Only qualified candidates need apply. Onsite AOH - Monday -
Friday - Standard 8-5. Very occasional need to have candidates work
later into the day due to occasional set up that may be needed.
Approximately 1-2x per month. Also, CANDIDATES MUST BE ABLE TO
TRAVEL INTERNATIONALLY. 3 Key Consulting is hiring an Engineer
Principal, Medical Device Process Development, for a consulting
engagement with our direct client, a leading global
biopharmaceutical company. Job Description: Our ideal candidate
will have 10 years of experience. (See below for details). This
position will be onsite in New Albany, OH., Monday - Friday -
Standard 8-5. Very occasional need to have candidates work later
into the day due to occasional set up that may be needed.
Approximately 1-2x per month. The qualified candidate will lead
teams in the development of drug delivery devices. Scope includes a
wide range of devices, such as; needle protection systems, fluid
transfer devices, pen injectors, automatic pen injectors, and
micro-infuser delivery pump systems. The qualified candidate will
lead technical teams to ensure successful device development of
these mechanical and electro-mechanical medical devices. The
Principle Engineer will work closely with team members to develop
detailed engineering specifications, device design & development,
support verification, validation, and regulatory submissions of
these devices. The role of the Principle Engineer is to work within
a cross-functional organization to utilize technologies and
methodologies that support short-cycle robust device development.
Responsibilities: Work cross-functionally with individuals and
project teams in Marketing, Operations, and Development - Create
and assess product requirements to determine technical coverage and
proper integration different subsystems. Create and execute to
project plans and schedules Develop, execute, and review
architecture documents, design documents, specifications,
development plans, characterization plan, verification and
validation plans and other related product development documents
for assigned projects. Provide deep technical assistance for junior
engineers. Why is the Position Open? Planned Project Top Must Have
Skills: The Principle Engineer will work closely with team members
to focus on the following skills: Develop, execute, and design
documents, specifications, development plans, characterization
plan, verification and validation plans and other related product
development documents for assigned projects. Experience with
material & test specs generation, protocol & report writing,
process & test development, prototyping, design verification,
DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. -
Product design/development (design control) from concept to post
product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k)
submissions. Strong problem solving, risk assessment, and risk
management skills and capable of working on multiple projects in a
deadline driven environment. Day to Day Responsibilities: Develop,
execute, and review architecture documents, design documents,
specifications, development plans, characterization plan,
verification and validation plans and other related product
development documents for assigned projects. In addition to
troubleshoot new equipment to be implemented. Basic Qualifications:
Doctorate degree and 3 years of experience OR Masters degree and 5
years of experience OR Bachelors degree and 7 years of experience
OR Associates degree and 12 years of experience OR High school
diploma / GED and 14 years of experience. BS in Engineering and
previous experience in a medical device industry 10 years current
experience with engineering processes and procedures. Led projects
from development through the 510k and PMA approval process. Strong
background in engineering and commercialization of
electro-mechanical medical devices. Experience with material & test
specs generation, protocol & report writing, process & test
development, prototyping, design verification, DOE/SPC process
optimization & validation (IQ, OQ, PQ), FMEA. Product
design/development (design control) from concept to post product
launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in drug/device combination product design and
development Familiar with the following standards: Quality System
Regulation 21CFR820 Risk Management ISO 14971 EU Medical Device
requirements Council Directive 93/42/EEC Medical Electrical
Equipment EN 60601 Small scale device assembly experience. Ability
to read, analyze, and interpret general business periodicals,
professional journals, technical procedures, or governmental
regulations. Strong problem solving, risk assessment, and risk
management skills. Must be capable of working on multiple projects
in a deadline driven environment. VERY IMPORTANT NOTE: Qualified
candidates with either a strong Electrical Engineering, Mechanical
Engineering, OR Systems/Software Engineering background need apply
and will be considered. Red Flags: Not flexible for the working
shift/hours required. Approximately 1-2x per month Interview
process: One round 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, Columbus , Engineer Principal, Drug Delivery Medical Device Process Development - (JP14606), Engineering , New Albany, Ohio
