Manufacturing Process Engineer – Medical Devices

Pentangle Tech Services | P5 Group; Cincinnati (OH); On-site; USD 85,000 - 120,000; Full time

Job summary

Pentangle Tech Services | P5 Group seeks an experienced Manufacturing Process Engineer to drive process improvements in a regulated manufacturing environment, ideally in medical devices. You will support operations, validate processes, and collaborate across Quality, R&D, and Regulatory teams.

The role emphasizes process capability, risk mitigation, and CAPA closure, with strong emphasis on documentation and continuous improvement in a fast-paced setting.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• Minimum 4 years of experience in Manufacturing Engineering/Process Engineering or Manufacturing Operations.
• Experience in medical device manufacturing or other regulated industries.
• Knowledge of PFMEA, CAPA, NCR, and QMS.
• Strong problem-solving and cross-functional collaboration skills.

Responsibilities

• Improve processes to achieve quality, productivity, cost, and delivery objectives.
• Identify and implement engineering solutions to eliminate safety and quality risks.
• Maintain and optimize manufacturing equipment, tooling, fixtures, and machinery.
• Lead cost reduction by minimizing scrap, rework, and consumable usage.
• Design, develop, and modify tools, fixtures, gauges, and equipment with internal teams and external suppliers.
• Develop robust manufacturing processes using structured engineering methodologies.
• Perform process capability studies, scrap and cost analyses to improve efficiency.
• Execute IQ, OQ, PQ validation in line with QMS requirements.
• Conduct Process Risk Assessments and PFMEA to mitigate risks.
• Prepare and maintain procedures, work instructions, specifications, and documentation.
• Support validation of new materials and process changes.
• Close CAPAs, NCRs, audit findings, and quality actions.
• Collaborate with Manufacturing, Quality, R&D, Supply Chain, Regulatory, and Suppliers.
• Utilize MS Office and project management tools.
• Support lab controls and supplier validations.

Skills

Process engineering

Analytical thinking

Cross-functional collaboration

Regulatory awareness

Communication

Education

Bachelor's degree in Mechanical Engineering

Tools

IQ/OQ/PQ

QMS

MS Office

Job description

Pentangle Tech Services | P5 Group seeks an experienced Manufacturing Process Engineer to drive process improvements in a regulated manufacturing environment, ideally in medical devices. You will support operations, validate processes, and collaborate across Quality, R&D, and Regulatory teams.

The role emphasizes process capability, risk mitigation, and CAPA closure, with strong emphasis on documentation and continuous improvement in a fast-paced setting.