Principal Scientist, Drug/Device Combination Products

This position will lead and implement medical device and combination product design controls for new products and inline products. The role will also lead and support continuous improvement initiatives related to design control and risk management processes.

Requirements

• Lead/Support continuous improvement initiatives for design control and risk management processes
• Identify and eliminate process inefficiencies using operational excellence tools
• Ensure processes align with regulatory requirements for medical device and drug combination products
• Collaborate with cross-function teams to improve processes related to device-drug integration
• Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations
• Conduct structured assessments of key quality and compliance programs to identify gaps against internal standards, regulatory expectations, and industry best practices
• Develop actionable remediation plans and drive their execution through to closure
• Lead/contribute to device development, design controls for the assigned projects
• Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Retirement benefits
• 401(k)
• Paid holidays
• Vacation days
• Compassionate and sick days