Sr. Director, Drug/Device Combination Products, Device Product Stewardship

Job Description The Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship for our company’s medical device and combination products (approximately 15 in total). This strategic leadership role will ensure that the portfolio overall and each product has robust lifecycle management plans, appropriate and rigorous technical support processes to support manufacturing sites, proactive risk management, performance monitoring, continuous improvement activities that ensure the safety, effectiveness, and compliance of the company's products. The organization will ensure post-market complaint technical oversight and rapid responses to early signals and trends with effective and statistically sound CAPA plans and issue resolution. The Senior Director will ensure stewards have the appropriate processes and playbooks, appropriate oversight, and that these processes communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive innovation in product stewardship. As a key senior member of the team, the role requires communication, influence, and alignment across multiple business units and sites within the manufacturing division. Key Responsibilities: Lead and provide strategic vision to the technical product stewardship department, overseeing technical support and product stewardship activities for approximately 15 inline medical device and combination products. Ensure staff has deep technical and leadership capabilities and processes to enable world class proactive manufacturing processes and rapid issue identification and resolution. Direct the development and implementation of proactive risk management strategies, including risk assessment, risk mitigation, and risk communication, to ensure the ongoing safety and efficacy of the company's product portfolio. Collaborate with cross-functional partners, including R&D, Quality, Regulatory, Manufacturing, Technical Product Leaders, and Value Chain to ensure comprehensive and effective technical support and product stewardship for inline products. Develop and maintain key performance indicators (KPIs) to measure the effectiveness and efficiency of technical support and product stewardship activities, and drive performance improvements as needed, such as the in process and release data, process health index, CAPA effectiveness, and complaint measures. Ensure standard work and processes, and drive continuous improvement initiatives to enhance technical support processes, optimize supply chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory requirements. Foster a culture of excellence, mentorship, and professional development within the technical product stewardship department, ensuring the growth and effectiveness of the team. Interface with regulatory authorities, industry organizations, and external partners to stay abreast of relevant regulations, standards, and best practices, and to represent the company's technical product stewardship capabilities. Qualifications: Bachelor's degree in engineering, life sciences, or related field. Advanced degree (Master’s or PhD) preferred. 15+ years of experience in medical device engineering, combination product development, or related technical fields, with a minimum of 5 years in a leadership or senior management position. Proven track record of effectively leading and managing a team supporting technical product stewardship, supply, or related functions. Strong understanding of medical device and combination product development and support from early stage through launch and supply, including mechanical systems design and manufacture, medical device design controls and device risk management, human factors evaluations, and design verification/validation. Significant experience in analytical method development and validation, including experience with a variety of analytical and materials characterization tools and techniques. Extensive knowledge of technical and global regulatory requirements for medical devices and combination products, including FDA, EU MDR, ISO, and other applicable guidelines. Excellent communication, negotiation, interpersonal skills, and problem-solving skills, with the ability to effectively engage with internal and external stakeholders and industry partners. Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship. Professional certifications (e.g., RAPS, ASQ, Six Sigma) and familiarity with statistical process control and improvement are highly desirable. Ability to drive change and lead teams in a fast-paced and dynamic environment.

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