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Manufacturing Process Engineer
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-09-07
Listing for:
Commissioning Partners
Full Time
position Listed on 2026-09-07
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Lean Manufacturing / Six Sigma, Manufacturing Engineer -
Manufacturing / Production
Quality Engineering, Lean Manufacturing / Six Sigma, Manufacturing Engineer
Job Description & How to Apply Below
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
- 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
- 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
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