Sr. Scientist, Drug/Device Combination Products, Design Controls (Hybrid)

Job Description

Job Description

The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device design control activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance.

Key Responsibilities and Activities:

The Senior Scientist, Device System – Device Design Control will be responsible for device design control activities in the following aspects:

• Lead and contribute device development design controls for the assigned projects. 

• Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.

• Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.

• Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device Development and with external suppliers.

• Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.

• Contribute to the development, implementation, and continuous enhancement of device design control processes, procedures, and tools.

• Participate in the strategic development of the Device Design Control function, contributing to team goals and initiatives.

Minimum education required:

• B.S or master's degree in Engineering, Science, or a related field plus 6 years of related experience.

Required experience and skills:

• Minimum of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area.

• Strong knowledge of regulatory requirements and industry standards related to device systems.

• Strong analytical and statistical skills with experience in data interpretation and risk assessment tools.

• Excellent communication, leadership, and problem-solving skills.

• Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

#eligibleforERP

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