Manufacturing Engineer Ii

Job Title : Manufacturing Engineer II
Location: Charlotte, NC
Pay rate : $42- 46/hr

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.

Recruiter Contact:
Name: Pavani Samboju
Email:
INTELLECTT INC

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.
Benefits: Employees hired into this position are eligible for the following benefits, subject to the 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 paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.