Scientist I​/II, Engineering - Design Verification Engineer

Responsibilities

• Serve as Subject Matter Expert (SME) on lab capabilities (GMP/non-GMP equipment, software, data acquisition) for Design Verification testing.
• Qualify equipment/software; develop/maintain SOPs and work instructions; resolve issues; train operators; represent combination product development on cross-functionally validated systems.
• Lead lab verification: develop protocols and test methods, execute tests, analyze data, write reports; support investigations and issue resolution; present results to cross-functional teams.
• Use volumetric accuracy equipment and force testing machine; familiarity with Zwick, viscometers, climate chambers is a plus.
• Support statistical data analysis (Mini Tab is a plus).
• Develop, validate, and transfer test methods.
• Use machine shop tools, Solid Works, and 3D printers to design and verify test fixtures.
• Prefer experience with Solid Works, Electronic Lab Notebook (ELN) software, and electronic DHF tools (e.g., Polarian).
• Work independently under guidance; comply with regulatory/safety requirements; collaborate with Quality, Regulatory Affairs, Clinical, and global partners.

• Bachelor’s (typically 10+ years) or Master’s (typically 8+ years) or PhD (no industry experience required).
• 3+ years in medical device or combination products.
• Experience with design control, risk management, and regulatory standards (ISO; FDA; ASTM).
• Knowledge of GMP, Design Controls, GDP, and FDA regulations; strong theoretical and practical understanding in scientific discipline.

paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k); eligible for short-term incentive programs.