Process Engineer in Cincinnati

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Job Description

Job Title: Process Engineer – Medical Devices

Location: Cincinnati, Ohio, USA

Work Type: On-site

Job Summary

We are seeking a Process Engineer to support manufacturing operations in a regulated medical device environment. The role focuses on developing, validating, and improving manufacturing processes to ensure consistent product quality, compliance, and operational efficiency.

Key Responsibilities

• Develop, optimize, and maintain manufacturing processes for medical device products.
• Execute and support process validation activities (IQ, OQ, PQ).
• Investigate manufacturing issues, perform root cause analysis, and support CAPA implementation.
• Create and maintain SOPs, work instructions, and process documentation.
• Collaborate with cross-functional teams including Manufacturing, Quality, and Engineering.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP requirements.
• Support change control activities and process risk assessments (PFMEA).
• Monitor process performance using SPC, yield, and defect metrics.
• Support new product introductions (NPI) and process transfers.

Required Qualifications

• Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial, Chemical, or related).
• 2–5 years' experience in medical device or regulated manufacturing.
• Experience with process validation and manufacturing documentation.
• Knowledge of Lean / Six Sigma methodologies.
• Strong analytical and problem-solving skills.
• Good communication and teamwork abilities.

Qualifications

• Experience in cleanroom or sterile manufacturing environments.
• Familiarity with risk management tools (FMEA).
• Six Sigma Green Belt certification.

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