3 Key Consulting, Inc. ยท 3 months ago
Engineer Principal, Drug Delivery Medical Device Process Development - (JP14606)
New Albany, Oh
Full-time
Onsite
Lead/Staff
$50/hr - $56/hr
10+ years exp3 Key Consulting, Inc. is hiring an Engineer Principal for a consulting engagement with a leading global biopharmaceutical company. The role involves leading teams in the development of drug delivery devices and ensuring successful device development of mechanical and electro-mechanical medical devices, while working within a cross-functional organization.
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Responsibilities
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
Qualification
Required
10 years of experience
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
Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase