Manufacturing Process Engineer

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

seeking an experienced Manufacturing Process Engineer to support manufacturing operations by driving process improvements, increasing productivity, reducing costs, and ensuring compliance with quality and regulatory standards. The ideal candidate will have experience in manufacturing engineering, process validation, risk management, and continuous improvement within a regulated manufacturing environment, preferably medical devices.

Key Responsibilities

• Support manufacturing operations by improving processes to achieve quality, productivity, cost, and delivery objectives.
• Identify and implement engineering solutions to eliminate safety and quality risks.
• Support maintenance and optimization of manufacturing equipment, tooling, fixtures, and machinery.
• Lead cost reduction initiatives by minimizing scrap, rework, and consumable usage.
• Design, develop, and modify manufacturing tools, fixtures, gauges, and special equipment in collaboration with internal teams and external suppliers.
• Develop robust, stable, and capable manufacturing processes using structured engineering methodologies.
• Perform process capability studies, scrap analysis, and cost analysis to improve manufacturing efficiency.
• Execute process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in compliance with Quality Management System (QMS) requirements.
• Conduct Process Risk Assessments and Process Failure Mode and Effects Analysis (PFMEA) to identify and mitigate manufacturing risks.
• Prepare and maintain manufacturing procedures, work instructions, specifications, and technical documentation.
• Support validation of new materials, consumables, and manufacturing process changes.
• Ensure timely closure of CAPAs, NCRs, audit findings, and other quality system actions.
• Collaborate with Manufacturing, Quality, R&D, Supply Chain, Regulatory, and Supplier teams to support continuous improvement initiatives.
• Utilize Microsoft Office applications and project management tools to support engineering activities.
• Support laboratory controls, supplier validations, material evaluations, and material specification updates where required.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• Minimum 4 years of experience in Manufacturing Engineering, Process Engineering, or Manufacturing Operations.
• Experience in medical device manufacturing or another regulated manufacturing industry.
• Strong knowledge of:
• Manufacturing Process Development
• Process Validation (IQ/OQ/PQ)
• PFMEA
• CAPA
• NCR
• Quality Management Systems (QMS)
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent communication and collaboration skills with cross-functional teams and external suppliers.

Preferred Qualifications

• Experience supporting continuous improvement, Lean Manufacturing, or Six Sigma initiatives.
• Experience with process capability studies, statistical analysis, and manufacturing optimization.
• Knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Experience supporting supplier qualification and validation activities.
• Familiarity with regulated manufacturing environments, including FDA and ISO quality standards.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and project planning tools.