Job Title: Manufacturing Engineer / Process Engineer – Medical Device
Location: Warsaw, Indiana (Fully Onsite)
Type: W2 Contract
Duration: Mar 2026 – Mar 2028
Note: Only Medical devices background can apply!
Job Summary
We are seeking a Manufacturing Engineer to support machining, metal finishing, and assembly operations in a regulated medical device manufacturing environment. The engineer will provide shop floor process support, process improvement initiatives, and validation activities while ensuring compliance with medical device quality standards.
Key Responsibilities
- Provide shop floor engineering support for machining, finishing, and assembly processes
- Maintain and update Manufacturing Process Planning documentation
- Drive process improvements and cost reduction initiatives
- Support CAPA, change control, and continuous improvement projects
- Assist with process validation and qualification studies
- Work with suppliers and purchasing teams to resolve technical manufacturing issues
- Maintain BOMs, routings, and production data within ERP systems
- Ensure compliance with medical device regulatory standards
Required Skills
- Experience with ERP systems (SAP)
- Knowledge of medical device quality systems and change control
- Experience supporting manufacturing processes (machining, assembly, metal finishing)
- Understanding of CAPA and process improvement initiatives
- Familiarity with medical device regulations such as
- ISO 13485
- 21 CFR Part 820
- EU MDR
Qualifications
- Bachelor’s Degree in Engineering (Mechanical, Manufacturing, Industrial, or related)
- Minimum 2+ years of manufacturing process support experience in a regulated environment
- Strong communication and problem-solving skills
