Process Development Engineer Med Device Packaging & Assembly

Intellectt INC

Columbus (OH)

On-site

USD 90,000 - 120,000

Full time

6 days ago

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Job summary

Intellectt INC is seeking a Process Development Engineer specializing in electro-mechanical medical devices and drug-device combinations. The role supports product development from concept to commercialization, including design, testing, validation, and regulatory activities.

You will lead cross-functional teams, develop specifications and validation plans, and perform design verification and process validation.

Qualifications

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.
Experience with prototyping, verification, and validation.

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.