Manufacturing Engineer Medical Devices

Overview:
Seeking a Manufacturing Engineer to provide hands-on support for medical device production, working closely with Quality Engineering and cross-functional teams. This role focuses on ensuring process readiness, improving operational efficiency, supporting new product development, and maintaining ongoing manufacturing operations to the highest safety, quality, and regulatory standards.

Key Responsibilities:

• Partner with Quality Engineering to ensure compliance with safety, quality, and regulatory requirements.

• Conduct time studies to optimize assembly line labor utilization and efficiency.

• Provide engineering support for projects, including change/risk analysis and manufacturing readiness assessments.

• Troubleshoot production issues impacting safety, quality, cost, or delivery.

• Perform qualification, verification, and validation (QV&V) activities for processes and equipment.

• Design, procure, and fabricate tooling and fixtures.

• Improve and document manufacturing processes to enhance yield, throughput, and performance.

• Train operators and technicians on new processes/equipment.

• Support new product development with process studies, Six Sigma methodologies, material testing, specification preparation, and report generation.

• Participate in design control activities, including FMEA and design reviews.

• Identify and implement cost-effective process improvements.

• Analyze process data and recommend enhancements.

Qualifications:

• Education:

  • BS in Packaging Science, Mechanical Engineering, or related field (MS preferred).

• Experience:

  • Minimum 6 years in packaging engineering, medical devices, pharmaceuticals, or related industry.

  • Strong mechanical/manufacturing engineering background.

  • Proven experience with medical device assembly lines.

  • Proficiency in time study analysis, process validation, and tooling design.

  • Knowledge of medical device manufacturing regulatory requirements.