Medical Device Process Engineer - Lean & CAPA

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

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.