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

Job summary :
Manufacturing Process Engineer with 5-10 years of experience in manufacturing engineering and operations within the medical device industry. Responsible for driving process improvements, supporting manufacturing operations, and delivering engineering solutions that improve quality, safety, productivity, and cost efficiency. Experience in process development, validation (IQ/OQ/PQ), PFMEA, CAPA/Client management, tooling and fixture development, material validations, and QMS compliance. Proven ability to optimize manufacturing processes, reduce waste, support supplier validations, and ensure regulatory compliance in a highly regulated environment.

Responsibilities :
• Mechanical Engineering with experience in manufacturing process and operations.
• Support attainment of key business metrics through the provision of engineering support for value stream processes.
• Elimination of safety and quality risks in the process through the delivery of robust engineering solutions.
• Machinery maintenance system support activities for equipment and fixtures.
• Manage costs through the delivery of scrap, reprocessing and consumable reduction projects.
• Modify & Develop tools, fixtures, gauges and special equipment for manufacturing operations in conjunction with Toolroom technicians and outside vendors.
• Develop stable and capable manufacturing process through a structured process development approach.
• Perform scrap and cost analysis based on evaluation of manufacturing process for minimizing waste and maximizing production.
• Ensure all process development, validation (IQ, OQ, PQ) etc. is managed in accordance with the Quality management system (QMS).
• Perform Risk Assessment on the process of development to highlight potential failure modes and evaluate identified risks using PFMEA.
• Preparation of all relevant manufacturing specifications.
• Competent in validation requirements for new consumables/materials and process changes.
• Update and maintenance of manufacturing specifications for process steps.
• Ensure timely closure of quality actions such as Audit Actions, Client's, CAPA's.
• Ensure all process development, validation, etc, is managed in accordance with the Quality management system.
• Personal computer software – Windows: word processing, project planning, presentation, e-mail.
• Implemented laboratory controls in the polymer lab based on internal regulatory compliance standards.
• Materials R&D SME/DRI for material supplier validations: analyzed supplier data, authored protocols and coordinated test specimens, and updated material specifications

Top Skills:
Manufacturing Process Development | Process Validation (IQ/OQ/PQ) | PFMEA | CAPA | Client | QMS | Risk Assessment | Manufacturing Operations | Tooling & Fixture Development | Scrap Reduction | Cost Optimization | Continuous Improvement | Medical Device Manufacturing | Supplier Validation | Root Cause Analysis

Additional Information:
• Bachelor in Mechanical Engineering or equivalent with 5-10 year's experience in manufacturing process and operations.
• Responsible for directing Manufacturing process improvement activities to ensure that the overall business objectives are achieved.
• Medical domain experience