Process Development Engineer/ Packaging & Assembly

Job Title: Process Development Engineer / Packaging & Assembly

Location: New Albany, OH

Job Summary

Seeking a Process Development Engineer with strong experience in electro-mechanical medical devices and drug-device combination products. The engineer will support product development from concept through commercialization, including design, testing, validation, and regulatory activities.

Key Responsibilities

• Lead cross-functional teams in medical device design and development.
• Support projects from concept through commercialization.
• Develop engineering specifications, design documents, test protocols, and validation plans.
• Perform/support design verification, validation, and process validation.
• Work with R&D, Quality, Operations, and Marketing teams.
• Support risk management, FMEA, DOE, SPC, and continuous improvement.
• Support IQ/OQ/PQ activities and prepare protocols/reports.
• Develop prototypes and conduct engineering testing.
• Provide technical guidance and mentor junior engineers.

Required Qualifications

• Strong experience in electro-mechanical medical device design and commercialization.
• Experience with drug-device combination products.
• Hands-on knowledge of Design Controls.
• Experience with FMEA, DOE, and SPC.
• Experience with IQ/OQ/PQ and process validation.
• Strong protocol and technical report writing skills.
• Experience with prototyping, verification, and validation.