Summary :
We are seeking 5 Mid to Senior Process Development Engineers with 10+ years of medical device experience to lead the development and commercialization of innovative drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, auto-injectors, and micro-infusion pump systems.
The engineer will provide technical leadership across the full product development lifecycle, from concept and design through verification, validation, regulatory approval, and commercialization.
Roles & Responsibilities :
Lead cross-functional teams in the design and development of mechanical and electro-mechanical medical devices.
Drive products from concept through commercialization, including verification, validation, and regulatory submissions.
Develop engineering specifications, design documentation, project plans, test protocols, and validation plans.
Support design controls, risk management, process validation, and continuous improvement initiatives.
Collaborate with Marketing, Operations, Quality, and R&D teams.
Provide technical leadership and mentor junior engineers.
Support FDA and international regulatory submission activities.
Education & Experience :
10+ years of medical device engineering experience.
Strong experience with electro-mechanical medical device design and commercialization.
Proven experience leading products through FDA 510(k), PMA, and CE Mark approvals.
Strong knowledge of design controls, risk management, verification, validation, and quality systems.
Experience leading cross-functional engineering/product development teams.
Numbers & Facts
Location
Cincinnati, OH
Skills
Continuous Improvementunmatched
Cross-Functionalunmatched
Design Verificationunmatched
Documentation Planunmatched
Drug Delivery Devicesunmatched
Electromechanical Designunmatched
Electromechanicsunmatched
Engineeringunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Infusion Pumpsunmatched
Leadershipunmatched
Marketingunmatched
Medical Equipmentunmatched
Mentoringunmatched
Process Developmentunmatched
Process Engineeringunmatched
Process Validationunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Project Planningunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Team Lead/Managerunmatched
Technical Leadershipunmatched
Testingunmatched
Validation Planunmatched
Validation Testingunmatched
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