Associate Engineer

Target PR Range: 25-35/hr
*Depending on experience

In this role, the candidate will work cross functionally supporting tech transfer activities for clinical and commercial with CMO sites, getting exposure to the FDP manufacturing processes for automated and HMLV (high mix low volume) processes for combination products (device assembly, labeling, and packaging). This includes identifying and exploring technologies in partnership with site PD, NPI lead, Validation Engineering, and Project Management.

Key Responsibilities:
• Support Tech Transfer activities
• Lead process gap assessment exercises
• Generate PTD (Process Transfer Document)
• Manage dashboards by updating KPI status and timelines
• Support characterization and PPQ activities at the receiving site
• Perform forensic analysis of devices
• Conduct root cause analysis using standard methodologies
• Leverage automation skillset to access and analyze equipment data
• Program within statistical analysis software or data tools such as MATLAB
• Update and optimize equipment automation recipes for quality, rapid device assembly
• Support design of test fixtures and/or assembly tools for manufacturing
• Troubleshoot device and equipment failure

This position is on site and might require to travel depending on the project/program needs.

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Ideal Qualifications:
• Engineering or biotechnology background
• Enthusiasm for new technology (digital and mechanical)
• Continuous improvement mindset
• Clear communication and presentation skills