Process Development Engineer/ Packaging & Assembly

Intellectt INC

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 .

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.

Apply

Vacancy posted 2 days ago

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