Process Development Engineer

Title: Process Development Engineer
Location: New Albany, OH
Duration: 12+ Months
Pay Rate: $48 $51/hr on W2
Type: Contract W2

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.

• 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.