Job Description
Job Summary: The Director of Device Product Stewardship will be responsible for leading technical support and product stewardship for several key products in our company’s medical device and combination products portfolio. This role will ensure the development and execution of robust lifecycle management plans, proactive risk management strategies, and continuous improvement initiatives to guarantee the safety, effectiveness, and compliance of our company's product portfolio. The product steward 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 Director will lead a team of technical experts and drive continuous improvement through proactive risk management and robust technical support processes. The Director will collaborate with cross-functional teams, manufacturing sites, and internal and external stakeholders to uphold the highest quality standards and drive robust product performance.
Essential Duties and Responsibilities:
- Provide strategic leadership and direction for technical support and product stewardship across assigned products, including managing ongoing changes to medical device and combination product designs and manufacturing processes. Develop, maintain, and refine technical product lifecycle management plans.
- Collaborate with cross-functional teams to ensure that all products meet safety, efficacy, and quality, and robust supply standards throughout their lifecycle.
- Lead, mentor, and develop a team of technical staff, providing guidance on industry best practices and fostering a culture of continuous improvement.
- Oversee lifecycle changes for products, ensuring internal quality and technical requirements are achieved, and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards, including FDA, EU MDR, ISO, and other applicable guidelines.
- Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
- Develop and maintain strong relationships with internal stakeholders, including R&D, quality, packaging, analytical, regulatory, manufacturing, Technical Product Leaders and Value Chain to facilitate effective technical support and product stewardship. This includes above site support for significant investigations, complaints monitoring (hypercare) and rapid response activities.
- Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical product stewardship activities.
Qualifications:
Minimum education required: Bachelor's degree in engineering, life sciences, or related field. Advanced degree (Master’s or PhD) preferred. 10+ years of experience in medical device engineering, combination product development, or related technical fields.
Required experience and skills:
- Demonstrated experience in a leadership role, managing 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.
- In-depth knowledge of global regulatory requirements for medical devices and combination products.
- Strong understanding of risk management principles, including ISO 14971 and other relevant standards.
- Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
- Proven track record of driving continuous improvement and implementing best practices in technical support and product stewardship.
- 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.
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