Medical Device Process Engineer – Continuous Improvement

TechDigital Group; Cincinnati (OH); On-site; USD 90,000 - 125,000; Full time

Job summary

TechDigital Group in Cincinnati, OH is seeking a Manufacturing Process Engineer with 5-10 years of medical device manufacturing experience to drive process improvements and support operations.

You will lead process development and IQ/OQ/PQ validation, perform PFMEA and CAPA, manage tooling and fixtures, and ensure QMS compliance while reducing waste and costs. Collaboration with suppliers and cross-functional teams is essential.

Qualifications

• Bachelor's in Mechanical Engineering with 5–10 years in manufacturing process and operations.
• Experience driving process improvements and ensuring QMS/compliance in medical devices.
• Proven ability to validate processes (IQ/OQ/PQ) and manage CAPA/ PFMEA.

Responsibilities

• Lead manufacturing process development and improvement initiatives.
• Support manufacturing operations to meet key metrics and quality targets.
• Perform risk assessments (PFMEA) and drive CAPA and corrective actions.
• Develop tools, fixtures, gauges, and fixtures with Toolroom/ vendors; manage costs.
• Ensure process validation, quality documentation, and QMS compliance.

Skills

Manufacturing Process Development

Process Validation IQ/OQ/PQ

PFMEA

CAPA

QMS

Risk Assessment

Manufacturing Operations

Tooling & Fixture Development

Scrap Reduction

Cost Optimization

Continuous Improvement

Medical Device Manufacturing

Supplier Validation

Root Cause Analysis

Education

Bachelor's in Mechanical Engineering

Job description

TechDigital Group in Cincinnati, OH is seeking a Manufacturing Process Engineer with 5-10 years of medical device manufacturing experience to drive process improvements and support operations.

You will lead process development and IQ/OQ/PQ validation, perform PFMEA and CAPA, manage tooling and fixtures, and ensure QMS compliance while reducing waste and costs. Collaboration with suppliers and cross-functional teams is essential.