Apply to Engineer Principal, Medical Device Development & Packaging C&Q - (JP14217)

Job Title: Engineer Principal, Medical Device Development & Packaging C&Q - (JP14217)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process development
Duration: 1+ years (with possible extension)
Posting Date: 07/07/25
Pay Rate: $51 - $56/hour W2
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.

3 Key Consulting is hiring an Engineer Principal, Medical Device Development & Packaging C&Q 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 candidate 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.

Why is the Position Open?
Planned Project

Top Must Have Skills:

Material & test specs generation, protocol & report writing.
Process & test development, prototyping, design verification.
DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Nice to have: packaging process experience

Day to Day Responsibilities:
Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Responsibilities include:

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.

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.