Engineer Principal, Medical Device Development & Packaging C&Q JP

Overview

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:
Onsite AOH - Monday - Friday - Standard 8-5. Very occasional need to work later for setup, 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. The ideal candidate will have 10 years of experience and will be onsite in New Albany, OH, with standard 8-5 hours and occasional later work as described above.

• The qualified candidate will lead teams in the development of drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
• Lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
• Work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions.
• Collaborate within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

• 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

• Support Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation.
• Gather user requirements and translate them into technical documentation for execution by third party firms.
• Cross-functional collaboration with Marketing, Operations, and Development to ensure project success.
• Create and assess product requirements for technical coverage and integration of subsystems.
• Develop, execute, and manage project plans and schedules.
• Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans, and other related product development documents.
• Provide deep technical assistance for junior engineers.

• Doctorate with 3+ years, or Masters with 5+ years, or Bachelors with 7+ years, or Associate with 12+ years, or High School/GED with 14+ years of experience.
• BS in Engineering and experience in a medical device industry.
• 10 years of current engineering experience with engineering processes and procedures.
• Led projects from development through the 510(k) and PMA approval processes.
• 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, IQ/OQ/PQ, FMEA.
• Product design/development (design control) from concept to post-launch for Europe (EMEA/CE Mark) and US (FDA/PMA/510(k)).
• Experience in drug/device combination product design and development.
• Familiar with standards:
  Quality System Regulation 21 CFR 820, ISO 14971, EU Medical Device Directive 93/42/EEC, EN 60601.
• Small-scale device assembly experience.
• Ability to read, analyze, and interpret technical documentation and regulations.
• Strong problem solving, risk assessment, and risk management skills.
• Ability to work on multiple projects in a deadline-driven environment.
• Note:
  
  Qualified candidates with strong Electrical, Mechanical, or Systems/Software Engineering backgrounds are encouraged to apply.

One round panel interview.

Interested candidates should send their resume to  For other opportunities, visit  or share this opportunity with others who may be interested.