Senior Principal Device Technical Working Group Lead – Senior Director Equivalent

Senior Principal Device Technical Working Group Lead – Senior Director Equivalent

Requirements

• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 15 years of combined experience in medical device and combination product development. Advanced degree is preferred.
• 5+ years of leadership experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product.
• 5+ years of leadership experience of managing complex device or combination product development programs and leading cross-disciplinary project teams.
• Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy.
• Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.
• Proven track record of applying analytical skills in product design, development, and validation
• Self-motivated with ability to work independently
• Proven ability to lead team members of diverse skill sets and backgrounds
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership
• Excellent communication, presentation, negotiation, project management, and organizational skills
• Experience with leading complex development projects at an enterprise level
• Willing to travel
• Able to multi-task continuously

Responsibilities

• Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:
• Lead the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions.
• Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.
• Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).
• Serve as key point-of-contact with potential external device designers, developers, and suppliers for selected device technology platforms.
• Oversee and serve as a technical integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis.
• Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy, timelines, milestones, and risks within our Company and with external suppliers
• Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
• Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.
• Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.
• Maintain a high level of engagement in the program-specific design controls process and design history file development.
• Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.
• Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.

Preferred Qualifications

• Advanced degree is preferred.