Manufacturing Engineer Ii

Job Title: Manufacturing Engineer II
Company: Intellectt Inc.
Location: Charlotte, NC
Work Environment: Onsite
payrate: $45/hour

Job Description:
Intellectt Inc. is a growing medical device manufacturer, is seeking a Manufacturing Engineer II to provide technical leadership for manufacturing processes supporting regulated medical device production. The successful candidate will drive process improvements, support product transfers and scale-up activities, execute validation efforts, and help improve manufacturing efficiency as production demand increases.

Key Responsibilities:

• Troubleshoot complex manufacturing issues and drive process improvements.
• Develop and execute IQ/OQ/PQ validation protocols and reports.
• Support new product introduction, manufacturing transfers, and scale-up.
• Lead CAPA, nonconformance, deviation, and root cause investigations.
• Improve manufacturing efficiency, quality, throughput, and cost.
• Develop fixtures, tooling, and manufacturing process solutions.
• Ensure compliance with FDA, cGMP, and quality system requirements.
• Collaborate with Quality, Operations, R&D, and Supply Chain teams

Must-Have Qualifications:

• Bachelor's degree in Engineering or a related field.
• 5 10 years of Manufacturing Engineering experience.
• Medical device manufacturing experience required.
• Strong knowledge of IQ/OQ/PQ, CAPA, RCA, and FDA/cGMP.
• Experience in process validation and continuous improvement.

Preferred: Disposable/single-use medical devices, manual assembly, Class II/III devices, Lean or Six Sigma.

Recruiter Contact
Soundarya Kondra
Email:
Phone:

Benefits

Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.