Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) - (JP15480)

Job Title: Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) - (JP15480)Location: New Albany, OH. 43054Employment Type: ContractBusiness Unit: Site Process DevelopmentDuration: 1+ year (with likely extensions and/or conversion to permanent)Posting Date: 06/15/26Pay Rate: $52 - $57/hour W2Notes: Only qualified candidates need apply. Onsite AOH - Monday- Friday- Standard 8-53 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 ProjectTop 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 experienceDay 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 monthUnable to travel internationallyInterview process: One round panel interviewWe 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.