Scientist I/II, Engineering - Design Verification Engineer

📋 Description

• Lead development of lab capabilities for Design Verification testing
• Qualify equipment, SOPs, and data systems; train operators
• Support design verification protocol development and data analysis
• Use lab equipment (volumetric devices, force test machines) and related tools
• Analyze data and document reports for cross-functional teams
• Work with cross-functional teams including Quality and Regulatory Affairs

🎯 Requirements

• Bachelor in Mechanical or Biomedical Eng; 5+ yrs (Scientist I) or 7+ yrs (Scientist II); Master’s
• 3+ yrs in pharma or medical device/combination products
• Knowledge of GMP, Design Controls, GDP, FDA regs
• Experience with ISO standards; design control and risk mgmt
• Strong problem solving, statistics knowledge; Six Sigma a plus
• Proficient with SolidWorks, ELN, Polarian; Cross-functional work

🎁 Benefits

• Comprehensive benefits including PTO and medical/dental/vision
• 401(k) for eligible employees
• Performance-based incentive programs