Process Development Engineer​/Packaging & Assembly

Job Title:

Process Development Engineer / Packaging & Assembly

Location:

New Albany, OH

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.

• 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.

• 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.

Equal Opportunity Employer We are an Equal Opportunity Employer and consider qualified applicants without regard to legally protected characteristics under applicable federal, state, and local laws.