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Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) (JP15480)
Job Location:
Job Location:
New Albany, OH - USA
Hourly Salary:
$ 52 - 57
Hourly Salary:
Posted:
17 June 2026 (30+ days ago)
Posted:
Application Deadline:
14 October 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title: Principal Engineer Drug Delivery Device Development (Electro-Mechanical Combination Products) - (JP15480)
Location: New Albany OH. 43054
Employment Type: Contract
Business Unit: Site Process Development
Duration: 1 year (with likely extensions and/or conversion to permanent)
Posting Date: 06/15/26
Pay Rate: $52 - $57/hour W2
Notes: Only qualified candidates need apply. Onsite AOH - Monday - Friday - Standard 8-5
3 Key Consulting is hiring a Principal Engineer Drug Delivery Device Development (Electro-Mechanical Combination Products) for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
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. International travel may be required for this position.
Candidate will lead teams in the development of drug delivery devices. Scope includes a wide range of devices such as:
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. They 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.
Basic Qualifications:
Red Flags:
Not flexible for the working shift/hours required and limitation to travel. Approximately 1-2x per month
Unable to travel internationally
Interview process:
One round panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: New Albany OH. 43054
Employment Type: Contract
Business Unit: Site Process Development
Duration: 1 year (with likely extensions and/or conversion to permanent)
Posting Date: 06/15/26
Pay Rate: $52 - $57/hour W2
Notes: Only qualified candidates need apply. Onsite AOH - Monday - Friday - Standard 8-5
3 Key Consulting is hiring a Principal Engineer Drug Delivery Device Development (Electro-Mechanical Combination Products) for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
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. International travel may be required for this position.
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
- 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. They 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.
- 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:
- BS in Engineering and previous experience in a medical device industry.
- 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
- 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 and limitation to travel. Approximately 1-2x per month
Unable to travel internationally
Interview process:
One round panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Required Experience:
Staff IC
