Director, Device System – Design Control

Job Description

The Director, Device System – Design Control plays a pivotal role in combination product development (both design and process), commercialization and lifecycle management. This person leads the design control team to ensure achievement of high-quality products and robust manufacturing processes.  This position will interact extensively with all subject-matter experts within the Device Development team as well as with members of numerous internal cross-functional product development teams from concept through product launch and post market surveillance. 

This Director role is responsible for building and managing a design control team that conduct Medical Device and Combination Product Design Control activities for both inline products and new products from early design concept definition through commercialization and post market surveillance.

Key Responsibilities and Activities:

The Director, Device System – Design Control will expand and manage a team that are responsible for design control activities in the following areas:

• Lead/contribute to device development and design controls strategy for both inline products and new products from early design concept definition through commercialization and post market surveillance.

• Lead the implementation and/or ensure effective execution of the device development strategy and design controls activities (such as develop design and development plan, identify design inputs requirements and rationale, create design trace matrix and control strategy) 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 approaches within Device Development and with external suppliers

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

• Lead the preparation of materials for program presentations for management review and regulatory submission.

• Contribute to the development, implementation, and continuous improvement of design controls processes, procedures, and tools.

• Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities

• Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others

Minimum education required:

• B.S and Master's degree in Engineering, Science, Business, or a related field plus 10 years of related experience.

Required experience and skill:

• Minimum of 10 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.

• Proven experience in team and people management

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

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

PSCS

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