Manufacturing Engineer

Manufacturing Engineer Full Time Monday - Friday Benefits: Medical, Dental, Vision, Critical Illness, Life, Short term disability, 401k w/ Company match, Bonus Program, Paid Holidays, PTO.

Position Overview

This position is created for a proactive and detail-oriented Manufacturing Engineer to bridge the gap between Engineering and Production in our ISO 13485-compliant medical device manufacturing environment.

This role is responsible for developing and maintaining robust manufacturing processes, documentation, and the utilization of our quality systems to ensure product reliability, regulatory compliance, and operational efficiency.

Essential Job Functions

Process Development & Documentation:

• Create and maintain manufacturing routers, work instructions, and standard operating procedures (SOPs).
• Develop and update process flow charts and PFMEAs
• Lead and support process validations (IQ/OQ/PQ) in accordance with ISO 13485 and FDA requirements.
• Conduct First Article Inspections (FAI) and ensure proper documentation and traceability.
• Coordinate with Quality to develop and maintain Production Part Approval Process documentation.
• Evaluate existing tools and fixtures for efficacy. Create new tools and fixtures to support production utilizing Solid Works when necessary.

Inspection and Quality Control

• Design and implement incoming inspection procedures for raw materials and components.
• Monitor and analyze non-conforming material, lead root cause investigations, and define rework processes.
• Support and participate in Corrective and Preventive Actions (CAPA).
• Conduct and analyze Statistical Process Control (SPC) studies to monitor and improve process performance.

Training and Support

• Train production personnel on new and revised manufacturing procedures and equipment.
• Provide technical support to resolve production issues and improve process capability.

Continuous Improvement

• Collaborate with cross-functional teams to identify and implement process improvements.
• Collaborate with cross-functional teams to reduce waste and improve efficiency.

Required Qualifications:

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical Engineering, or related field.
• Minimum of 3-5 years of experience in a regulated manufacturing environment, preferably medical devices.
• Strong working knowledge of ISO 13485.
• Experience with process validation, FAI, PFMEA, SPC, and PPAP documentation.
• Proficiency in CAD software, ERP systems, and Microsoft Office Suite.
• Excellent documentation, communication, and organizational skills.

Preferred Skills:

• Familiarity with risk management tools and statistical analysis software (e.g., Minitab).