Senior Manufacturing Engineer

Hi,

My name is Sravani Dasari from Vakula Tech Inc. We are hiring talented professionals for a Senior Manufacturing Engineer position. If you have relevant experience and are interested in this opportunity, the detailed job description is as follows.

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.

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Thank you,

Sravani Dasari

Talent Acquisition Specialist

Vakula Tech Inc.

Email:

Piscataway, New Jersey 08854

Website: