Position: Senior Manufacturing Engineer
Location: Indiana
Duration: Long Term
Job Overview
We are seeking an experienced Senior Manufacturing Engineer to support manufacturing process development, equipment validation, and continuous improvement activities in a regulated medical device or pharmaceutical manufacturing environment. The ideal candidate will have strong experience in validation, quality systems, process optimization, and manufacturing engineering.
Key Responsibilities
- Lead equipment qualification activities, including IQ, OQ, and PQ.
- Develop and execute validation protocols and prepare validation reports.
- Support manufacturing process improvements and equipment optimization.
- Perform risk assessments, including FMEA, and support CAPA activities.
- Conduct process capability studies using statistical tools such as Minitab or JMP.
- Support metrology, calibration, Gauge R&R, and measurement system analysis.
- Ensure compliance with ISO 13485, GMP, and 21 CFR Part 820 requirements.
- Maintain validation and quality documentation using eQMS and document control systems.
- Collaborate with cross-functional teams to resolve manufacturing and quality issues.
- Support continuous improvement and validation projects.
Required Qualifications
- 5 10 years of manufacturing engineering experience in a regulated medical device, pharmaceutical, or healthcare environment.
- Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or a related discipline.
- Hands-on experience with IQ/OQ/PQ validation activities.
- Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820.
- Experience with FMEA, CAPA, metrology, and calibration.
- Knowledge of CNC machining, CAM software, and basic CNC programming.
- Experience using Minitab, JMP, or similar statistical analysis tools.
- Familiarity with MasterControl, ETQ, or other eQMS/document control systems.
- Strong analytical, troubleshooting, and communication skills.