Hello

Hope you are doing well.

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to or call me at +1(732)-276-1791

Role: Manufacturing Engineer

Location: Minnetonka, MN - 55345

Duration: 9 Months

Shift Timings: 8:00 AM to 5:00 PM

Job Responsibilities:

Prepare assessments to ensure validated critical operating parameters meet qualified standards.

Generate and execute validation protocols (IQ, OQ, PQ, TMV, TQF, Process Characterization, and Process Validation) based on equipment capabilities.

Conduct installation, operational, and performance qualification studies for process equipment to ensure functionality.

New Product Introduction (NPI) & Process Transfer

Support NPI and process transfer activities in a regulated manufacturing environment.

Perform additional duties as assigned.

Preferred Qualifications:

Prior experience in medical device manufacturing or other regulated industries.

Knowledge of applicable industry standards and regulatory requirements (e.g., ISO 13485, FDA regulations).

Familiarity with statistical analysis tools and process improvement methodologies (e.g., Six Sigma).