Principal Research Scientist II

📋 Description

• Lead device and combination product development within Injection Device Development in Operations.
• Provide technical leadership for design, regulatory readiness, and lifecycle management of devices.
• Drive cross-functional collaboration across operations, R&D, quality, regulatory, and
• Translate technical strategy into executable plans and milestones.
• Evaluate emerging technologies and regulatory trends; translate insights into action.
• Mentor technical colleagues and present study results to varied audiences.

🎯 Requirements

• Bachelor’s degree in Mechanical Engineering or related field with 16 years of experience; Master’s
• Experience leading device or combination product development in a regulated environment.
• Knowledge of design controls (21 CFR 820 / ISO 13485 Design Controls), risk management
• Strong ability to turn technical strategy into executable plans; track record of product launches
• Excellent collaboration and communication; experience mentoring others and influencing without
• Working knowledge of regulatory expectations and industry standards; ability to manage multiple

🎁 Benefits

• Comprehensive benefits package including PTO, medical/dental/vision, and 401(k).
• Eligible for long-term incentive programs.