Director, Device System – Device Risk Management

Job Description

The Director, Device System – Device Risk Management plays a pivotal role in combination product development (both design and process), commercialization and lifecycle management. This person leads the device risk management 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 device risk management team that conduct Medical Device and Combination Product Device risk management 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 – Device Risk Management will expand and manage a team that are responsible for device risk management activities in the following areas:

• Lead/contribute to device risk management 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 risk management strategy and activities (such as create device risk management plan/report, conduct system hazard analysis and FMEA and perform overall device risk evaluation) 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 risk management strategy and approaches within Device Development and with external suppliers

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

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

• Contribute to the development, implementation, and continuous improvement of device risk management 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 skills:

• 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

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights