Manufacturing Engineer II

Job Title: Manufacturing Engineer II
Company: Intellectt Inc.
Location: Charlotte, NC
Employment Type: W2 Contract
Pay Rate: $45-50/hr
Work Arrangement: Onsite
Shift: Second Shift

Position Summary

Our client, 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.

Responsibilities

- Lead investigations and resolution of complex manufacturing issues.
- Drive process improvements focused on quality, throughput, and cost reduction.
- Author and execute validation documentation, including IQ/OQ/PQ protocols and reports.
- Support manufacturing transfers and new product introduction activities.
- Lead and participate in nonconformance, deviation, and CAPA investigations.
- Develop and implement manufacturing process improvements, fixtures, and tooling solutions.
- Analyze production metrics to identify opportunities for operational improvements.
- Provide technical guidance to manufacturing personnel and junior engineers.
- Collaborate with Quality, Operations, R&D, and Supply Chain teams to support business objectives.
- Ensure manufacturing processes remain compliant with regulatory and quality requirements.


Qualifications

- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or related discipline.
- 5-10 years of Manufacturing Engineering experience.
- Medical device manufacturing experience required.
- Strong knowledge of cGMP, FDA-regulated environments, and quality systems.
- Experience supporting process validation, manufacturing scale-up, and process optimization initiatives.
- Experience with disposable or single-use medical devices preferred.
- Experience supporting manual assembly manufacturing operations preferred.
- Strong troubleshooting, leadership, and communication skills.


Preferred Skills

- Process validation ownership (IQ/OQ/PQ).
- CAPA, nonconformance, and root cause investigation experience.
- Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
- Experience supporting Class II and/or Class III medical devices.

Key Skills:

Medical device manufacturing engineering, process validation (IQ/OQ/PQ), process improvement and optimization, root cause analysis, CAPA and nonconformance investigations, manufacturing scale-up and product transfer, new product introduction (NPI), tooling and fixture development, Lean Manufacturing/Six Sigma, cGMP/FDA compliance, and manual assembly or single-use medical device manufacturing experience.

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.