3 Key Consulting, Inc.
Engineer Principal, Drug Delivery Medical Device Process Development - (JP14606)
3 Key Consulting, Inc., New Albany, Ohio, United States, 43054
Job Overview
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 Onsite: Monday – Friday, Standard 8–5. Very occasional need to work later due to setup (approximately 1–2x per month). Candidates must be able to travel internationally. Direct message the job poster from 3 Key Consulting, Inc. This is a consulting engagement with a leading global biopharmaceutical company. Notes: Only qualified candidates need apply. Responsibilities
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 mechanical and electro-mechanical medical devices. Collaborate with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions. Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Work cross-functionally with Marketing, Operations, and Development to create and assess product requirements and determine technical coverage and proper integration of subsystems. Create and execute 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. 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 with previous experience in a medical device industry. 10 years of current experience with engineering processes and procedures. Led projects from development through 510(k) and PMA approvals. Strong background in engineering and commercialization of electro-mechanical medical devices. Experience with material & test specifications 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-launch for Europe (EMEA/CE Mark) and US (FDA/PMA/510(k)) submissions. Experience in drug/device combination product design and development. Familiar with standards: 21CFR820, EU Medical Device Directive 93/42/EEC, EN 60601. Ability to read, analyze, and interpret technical and regulatory documents. Strong problem solving, risk assessment, and risk management skills; ability to manage multiple projects in a deadline-driven environment. Qualified candidates with a strong Electrical, Mechanical, or Systems/Software Engineering background will be considered. Day-to-Day and Special Considerations
Day-to-day: Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans, and related product development documents for assigned projects; troubleshoot new equipment as needed. Why this Position is Open
Planned project Travel and Schedule
Onsite in New Albany, OH; occasional international travel required; typical hours 8–5, with rare after-hours for setup as noted. Application Instructions
Qualified candidates may send resumes to resumes@3keyconsulting.com. For other openings, visit www.3keyconsulting.com/careers. Seniority level: Mid-Senior level Employment type: Contract Industries: Pharmaceutical Manufacturing and Biotechnology
#J-18808-Ljbffr
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 Onsite: Monday – Friday, Standard 8–5. Very occasional need to work later due to setup (approximately 1–2x per month). Candidates must be able to travel internationally. Direct message the job poster from 3 Key Consulting, Inc. This is a consulting engagement with a leading global biopharmaceutical company. Notes: Only qualified candidates need apply. Responsibilities
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 mechanical and electro-mechanical medical devices. Collaborate with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions. Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Work cross-functionally with Marketing, Operations, and Development to create and assess product requirements and determine technical coverage and proper integration of subsystems. Create and execute 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. 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 with previous experience in a medical device industry. 10 years of current experience with engineering processes and procedures. Led projects from development through 510(k) and PMA approvals. Strong background in engineering and commercialization of electro-mechanical medical devices. Experience with material & test specifications 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-launch for Europe (EMEA/CE Mark) and US (FDA/PMA/510(k)) submissions. Experience in drug/device combination product design and development. Familiar with standards: 21CFR820, EU Medical Device Directive 93/42/EEC, EN 60601. Ability to read, analyze, and interpret technical and regulatory documents. Strong problem solving, risk assessment, and risk management skills; ability to manage multiple projects in a deadline-driven environment. Qualified candidates with a strong Electrical, Mechanical, or Systems/Software Engineering background will be considered. Day-to-Day and Special Considerations
Day-to-day: Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans, and related product development documents for assigned projects; troubleshoot new equipment as needed. Why this Position is Open
Planned project Travel and Schedule
Onsite in New Albany, OH; occasional international travel required; typical hours 8–5, with rare after-hours for setup as noted. Application Instructions
Qualified candidates may send resumes to resumes@3keyconsulting.com. For other openings, visit www.3keyconsulting.com/careers. Seniority level: Mid-Senior level Employment type: Contract Industries: Pharmaceutical Manufacturing and Biotechnology
#J-18808-Ljbffr