Description

You will manage the transfer of combination product test methods to manufacturing, ensuring quality, reliability, and cost efficiency through rigorous engineering processes.

Responsibilities

• Develop physical test methods for medical devices and combination product systems using core engineering principles.
• Perform data analysis to support method development, qualification, validation, and transfer.
• Design or redesign tools and equipment for manufacturing processes, coordinating delivery with contractors.
• Execute investigations and develop new processes to improve quality and reduce costs.
• Maintain integrated project timelines and facilitate communication to manage risks and deliverables.

Required Skills

• 5+ years of experience in product engineering or manufacturing engineering roles.
• Proficiency in statistical data analysis using JMP or Minitab.
• Hands-on experience modeling test fixtures and reference samples using SolidWorks or other CAD software.
• Proven experience with root cause analysis, CAPA, and deviation management.
• Experience in equipment, method, and test validation.
• Strong technical writing skills for generating procedures and documentation.
• Ability to manage project schedules, budgets, and supervise support staff during system development.

Preferred Skills

• K knowledge of equipment and software IOQ, process characterization, and scale-up.
• Experience with combination products, device regulatory requirements, and cGMPs for sterile injectable products.

Key Skills

Education

Any Graduate