Job Description
The Associate Principal Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance.
Key Responsibilities and Activities:
- Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept through commercialization and post-market evaluation.
- Develop and execute the device risk management strategy, including the creation of device risk management plans and reports, conducting system hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with corporate policies and communicate effectively with cross-functional stakeholders and external suppliers.
- Support Design Transfer activities to internal and external sites ensuring proper translation and implementation of risk control measures.
- Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management decisions and strategies.
- Utilize statistical methods to interpret risk data, providing clear and actionable recommendations rooted in empirical evidence.
- Work collaboratively with cross-functional teams to embed risk management processes into the overall product development lifecycle.
- Proactively identify and address project challenges, effectively communicating risk management strategies within the Device Development team and with external partners.
- Understand and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards.
- Lead risk management workshops and training programs, facilitating knowledge transfer for internal and external manufacturing sites to strengthen awareness of risk management principles across teams. Mentor junior risk management leads and cross-functional partners to promote best practices.
- Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.
- Contribute to the development, implementation, and continuous enhancement of device risk management processes, procedures, and tools.
- Enhance the company's professional image and competitive position through publications, presentations, patents, and active participation in professional activities.
- Stay informed of regulatory changes and industry best practices to maintain the effectiveness and relevance of our risk management strategies, sharing this knowledge with others in the organization.
- Participate in the strategic development of the Device Risk Management function, contributing to team goals and initiatives.
Minimum education required:
- B.S and Master's degree in Engineering, Science, Business, or a related field plus 8 years of related experience.
Required experience and skills:
- Minimum of 8 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.
- Strong analytical and statistical skills with experience in data interpretation and risk assessment tools.
- Excellent communication, leadership, and problem-solving skills.
- Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.
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