Manufacturing Engineer II

Planet Pharma; Charlotte (NC); On-site; USD 76,000 - 90,000; Part time

Job summary

Planet Pharma in Charlotte, NC is seeking a Manufacturing Engineer II to provide technical leadership for manufacturing processes supporting regulated medical device production. You will drive process improvements, support product transfers and scale-up activities, execute validation efforts, and help improve manufacturing efficiency as demand increases.

The role requires a Bachelor’s in engineering, 5–10 years in manufacturing engineering, and strong knowledge of cGMP, FDA‑regulated

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.

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.

Skills

Troubleshooting

Leadership

Communication

Education

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or related discipline

Tools

IQ/OQ/PQ validation

CAPA systems

Lean Manufacturing tools

Job description

Manufacturing Engineer II

Location: Charlotte, NC (Onsite)
Duration: 6-Month Contract (Potential Extension and/or Conversion to Permanent)

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.

Target Compensation

• Pay Rate: $55-$65/hour