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.
Numbers & Facts
Location
NULL, OH
Skills
Continuous Improvementunmatched
Cross-Functionalunmatched
Design Documentunmatched
Design Verificationunmatched
Electromechanical Designunmatched
Electromechanicsunmatched
Failure Mode and Effects Analysis (FMEA)unmatched
Federal Laws and Regulationsunmatched
Marketingunmatched
Medical Equipmentunmatched
Mentoringunmatched
Process Developmentunmatched
Process Engineeringunmatched
Process Validationunmatched
Product Developmentunmatched
Product Engineeringunmatched
Product Packagingunmatched
Product Supportunmatched
Prototypingunmatched
Regulationsunmatched
Reporting Skillsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
State Laws and Regulationsunmatched
Team Lead/Managerunmatched
Technical Leadershipunmatched
Technical Writingunmatched
Test Designunmatched
Testingunmatched
United States Department of Energy (DOE)unmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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