Manufacturing Process Engineer

Commissioning Partners; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Commissioning Partners is looking for a Manufacturing Process Engineer in Indianapolis. The ideal candidate should have at least 3 years of experience in the Medical Device industry, focusing on process optimization, compliance, and improvements.

The role involves developing and validating manufacturing processes while ensuring adherence to FDA and ISO regulations. Strong problem-solving and teamwork skills are essential. This position offers opportunities for continuous improvement initiatives in a dynamic environment.

Qualifications

• 3+ years of Manufacturing Process Engineering experience in the Medical Device industry.
• Experience with process validation (IQ/OQ/PQ) and manufacturing process development.
• Strong knowledge of FDA regulations, ISO 13485, GMP.

Responsibilities

• Develop, implement, and optimize manufacturing processes to improve quality and efficiency.
• Support process validation activities including IQ, OQ, PQ.
• Investigate manufacturing issues and implement corrective actions.

Skills

Process optimization

Root cause analysis

Problem-solving

Communication skills

Continuous improvement

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

Lean Manufacturing

Six Sigma

Job description

Overview

We are seeking a Manufacturing Process Engineer with at least 3 years of experience in the Medical Device industry to support manufacturing operations, process optimization, and continuous improvement initiatives. The ideal candidate will be responsible for developing, validating, and improving manufacturing processes while ensuring compliance with FDA, ISO 13485, GMP, and other regulatory requirements.

Key Responsibilities

• Develop, implement, and optimize manufacturing processes to improve product quality, efficiency, and cost-effectiveness
• Support process validation activities including IQ, OQ, PQ, and process capability studies
• Investigate manufacturing issues, identify root causes, and implement corrective and preventive actions (CAPA)
• Collaborate with Quality, R&D, Operations, and Supply Chain teams to support new product introductions and process transfers
• Prepare and maintain manufacturing documentation, work instructions, SOPs, and process specifications
• Monitor manufacturing performance metrics and drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies
• Support equipment qualification, maintenance, and troubleshooting activities
• Ensure compliance with FDA regulations, ISO 13485 standards, GMP requirements, and internal quality procedures
• Participate in risk assessments, FMEA activities, and change control processes
• Support audits, inspections, and regulatory submissions as required

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Manufacturing Engineering, or a related field
• Minimum 3 years of Manufacturing Process Engineering experience in the Medical Device industry
• Experience with process validation (IQ/OQ/PQ) and manufacturing process development
• Knowledge of FDA regulations, ISO 13485, GMP, and quality systems
• Experience with root cause analysis, CAPA, and continuous improvement methodologies
• Strong problem-solving, analytical, and communication skills
• Ability to work effectively in a cross-functional team environment

Preferred Qualifications

• Experience with Lean Manufacturing, Six Sigma, or other process improvement methodologies
• Knowledge of risk management tools such as FMEA
• Experience supporting new product introductions (NPI) and manufacturing transfers