Manufacturing Engineer – Medical Devices / NPI

Job Title: Manufacturing Engineer Medical Devices / NPI
Company: Intellectt Inc.
Location: Hialeah, FL
Employment Type: W2 Contract
Pay Rate: $45-50/hr
Work Arrangement: Onsite

Job Summary

Seeking an experienced Manufacturing Engineer to support a large-scale new product introduction (NPI) for a medical device product line comprising approximately 24 SKUs. The engineer will own manufacturing processes from component fabrication through subcomponent assembly, supporting precision operations such as CNC machining and laser welding.

Key Responsibilities

• Develop, integrate, and improve manufacturing processes for new medical device products.
• Support CNC machining, laser welding, precision component fabrication, and subcomponent assembly.
• Develop and execute Operational Qualification (OQ) and Performance Qualification (PQ) protocols; document results and resolve qualification issues.
• Design, develop, and implement manufacturing tooling and fixtures.
• Author and update manufacturing work instructions and train production personnel.
• Serve as the process owner, troubleshooting manufacturing issues and implementing process improvements.
• Collaborate with Manufacturing, Quality, Engineering, and Production teams to ensure successful product integration and production readiness.
• Provide weekend support when required to meet project milestones.

Required Qualifications

• At least 5 years of hands-on manufacturing engineering experience.
• Strong technical experience with CNC machining and precision manufacturing operations.
• Hands-on experience developing and executing process qualifications, particularly OQ/PQ.
• Experience designing and developing manufacturing tooling and fixtures.
• Experience supporting NPI, process development, and production integration.
• Ability to prepare clear work instructions and train production personnel.
• Strong troubleshooting, problem-solving, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Medical device manufacturing experience, particularly in contract manufacturing.
• Experience manufacturing surgical instruments.
• Experience with laser welding and precision assembly processes.

Key Skills:

Manufacturing Engineering, CNC Machining, Medical Devices, NPI, OQ/PQ, Tooling and Fixtures, Laser Welding, Work Instructions.

Recruiter Contact:

Rudra Prasad Kunnath
Email:

prasad.kunnath@intellectt.com

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.