Title: Process Development Engineer Location: New Albany, OH Duration: 12+ Months Pay Rate: $48 $51/hr on W2 Type: Contract W2
Job Summary
We are seeking an experienced Process Development Engineer to support the design, development, and commercialization of mechanical and electro-mechanical drug delivery devices. This role will lead and support cross-functional engineering activities throughout the product development lifecycle, including design controls, prototyping, verification and validation, process validation, risk management, and regulatory submission support.
Key Responsibilities
Lead cross-functional activities for the design and development of mechanical and electro-mechanical drug delivery devices.
Drive product development projects from concept and prototyping through commercialization.
Develop engineering specifications, design documentation, project plans, test protocols, and validation plans.
Support design verification and validation (V&V) activities.
Lead and support IQ/OQ/PQ and process validation activities.
Perform risk management activities, including FMEA, and support DOE and SPC activities.
Support prototyping, testing, troubleshooting, and continuous improvement initiatives.
Collaborate with R&D, Quality, Operations, Marketing, and Regulatory teams.
Support technical documentation required for regulatory submissions.
Provide technical leadership and mentorship to junior engineers.
Required Qualifications
Strong experience in electro-mechanical medical device design and development.
Experience with drug delivery devices or drug/device combination products.
Strong knowledge of Design Controls and product development lifecycle.
Hands-on experience with verification, validation, and process validation.
Experience with IQ/OQ/PQ, FMEA, DOE, and SPC.
Experience developing and executing test protocols and validation plans.
Strong technical writing, problem-solving, and cross-functional collaboration skills.
Experience supporting medical device products through commercialization is highly preferred.
Numbers & Facts
Location
New Albany, OH
Salary
$48–$51
Skills
Continuous Improvementunmatched
Cross-Functionalunmatched
Design Verificationunmatched
Documentation Planunmatched
Drug Delivery Devicesunmatched
Electromechanical Designunmatched
Electromechanicsunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
Marketingunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Mentoringunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Process Engineeringunmatched
Process Validationunmatched
Product Designunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Product Supportunmatched
Product/Service Launchunmatched
Project Planningunmatched
Prototypingunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Support Documentationunmatched
Team Playerunmatched
Technical Leadershipunmatched
Technical Supportunmatched
Technical Writingunmatched
Test Plan/Scheduleunmatched
Testingunmatched
United States Department of Energy (DOE)unmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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