Senior Scientist - Design Control (Hybrid)

About the role

The Senior Scientist, Device Design Control Lead, will drive design control activities for combination product development, commercialization, and lifecycle management. This hybrid position collaborates with cross‑functional teams from concept through launch and post‑market surveillance.

Key responsibilities

• Lead and contribute device development design controls for assigned projects, preparing materials for management presentations and regulatory submissions.
• Implement and ensure execution of device development strategy and design controls, communicating with internal stakeholders and external suppliers.
• Resolve project obstacles proactively and apply regulatory and risk‑management requirements.
• Contribute to continuous improvement of design control processes, procedures, and tools.

Required profile

• B.S. or master’s degree in Engineering, Science or related field with at least 6 years of relevant experience.
• Minimum 6 years in pharmaceutical/device development, quality management or related area.
• Strong knowledge of regulatory requirements and industry standards for medical devices.
• Excellent communication, leadership and problem‑solving abilities in a fast‑paced environment.

Required skills

• Analytical Method Development
• Geometric Dimensioning And Tolerancing (GD&T)
• ISO 13485 Medical Devices
• Mechanical Design and Testing
• Method Validation
• Product Development and Prototyping
• Statistical Analysis
• Technical Writing

What we offer

• Comprehensive medical, dental and vision insurance for employee and family.
• Retirement benefits including 401(k) plan.
• Paid holidays, vacation, compassionate and sick days.
• Eligibility for annual bonus and long‑term incentive plans.