Process Development Engineer/ Packaging & Assembly

Intellectt INC; Columbus (OH); On-site; USD 90,000 - 120,000; Full time

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.

Skills

Electro-mech design

Drug-device combos

Design Controls

FMEA

DOE

SPC

IQ/OQ/PQ

Process validation

Prototyping

Technical reporting

Mentoring

Job description

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