Manufacturing Engineer I

Planet Pharma; Charlotte (NC); Sur place; USD 48 000 - 69 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Manufacturing Engineer I to support daily operations, process development, and scale-up for disposable medical devices. This onsite, 6-month contract role focuses on improving product quality, efficiency, and adherence to cGMP within a regulated manufacturing environment.

The candidate will collaborate with Quality, Operations, Supply Chain, and Engineering to drive process improvements and ensure successful product introductions while maintaining documentation and

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• 2-5 years of Manufacturing Engineering experience.
• Experience in a regulated manufacturing environment.
• Knowledge of cGMP and quality system requirements.
• Experience supporting manual assembly manufacturing processes.
• Medical device manufacturing experience preferred.
• Experience with disposable or single-use medical devices preferred.
• Strong analytical, problem-solving, and communication skills.

Responsabilités

• Support daily manufacturing operations and troubleshoot production-related issues.
• Assist with process development, process optimization, and continuous improvement initiatives.
• Develop, maintain, and revise manufacturing procedures, work instructions, and related documentation.
• Support investigations involving nonconformances, deviations, and CAPA activities.
• Participate in process validation and equipment qualification activities.
• Analyze manufacturing data to identify trends and improvement opportunities.
• Collaborate with Quality, Operations, Supply Chain, and Engineering teams to ensure efficient production.
• Support implementation of manufacturing changes and new product introductions.
• Ensure compliance with applicable quality system requirements and cGMP standards.

Connaissances

Analytical skills

Problem-solving

Communication

Formation

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

Description du poste

Manufacturing Engineer I

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

Position Summary

Our client, a leading medical device manufacturer, is seeking a Manufacturing Engineer I to support manufacturing operations, process improvements, and production scale-up activities within a regulated environment. This individual will partner with cross-functional teams to improve product quality, increase manufacturing efficiency, and support ongoing production of disposable medical devices.

Responsibilities

• Support daily manufacturing operations and troubleshoot production-related issues.
• Assist with process development, process optimization, and continuous improvement initiatives.
• Develop, maintain, and revise manufacturing procedures, work instructions, and related documentation.
• Support investigations involving nonconformances, deviations, and CAPA activities.
• Participate in process validation and equipment qualification activities.
• Analyze manufacturing data to identify trends and improvement opportunities.
• Collaborate with Quality, Operations, Supply Chain, and Engineering teams to ensure efficient production.
• Support implementation of manufacturing changes and new product introductions.
• Ensure compliance with applicable quality system requirements and cGMP standards.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or related discipline.
• 2-5 years of Manufacturing Engineering experience.
• Experience working within a regulated manufacturing environment.
• Knowledge of cGMP and quality system requirements.
• Experience supporting manual assembly manufacturing processes.
• Medical device manufacturing experience strongly preferred.
• Experience with disposable or single-use medical devices preferred.
• Strong analytical, problem-solving, and communication skills.

Preferred Skills

• Root cause analysis tools.
• Process validation support.
• Lean Manufacturing and continuous improvement methodologies.
• Technical documentation and change control experience.

Target Compensation

• Pay Rate: $35-$50/hour