Director, Design Assurance

Director, Design Assurance

Location:

Newark, DE (Hybrid).

• Direct the Design Assurance organization to support new product development and sustain activities for Breast and Skeletal Health (BSH) products.
• Ensure appropriate organizational structure and personnel development to meet divisional strategies and goals.

• Lead the BSH Design Assurance team, including managers and Design Assurance engineers.
• Oversee activities, set goals, manage project resourcing, and provide guidance for product support.
• Recruit, retain, and manage multiple direct reports, focusing on performance management, employee development, mentoring, and coaching to maximize engagement and productivity.

• Promote awareness and efficacy of design control and risk management procedures/processes.
• Drive continuous improvements through collaborative relationships with stakeholders.
• Develop and oversee the application of design controls and risk management while supporting product development, manufacturing‑related design changes, maintaining regulatory compliance, and enhancing manufacturability and cost efficiency.

• Direct activities, establish goals and objectives, define expected performance, and provide daily support and regular feedback regarding execution.
• Assess the skillsets, competencies, and organization structure of the Design Assurance function, developing strategies and plans to meet current and future needs.
• Consult with stakeholders to understand and plan for business strategies and needs.

• Provide guidance to managers and Design Assurance Engineers on design control compliance requirements.
• Address technical and project‑based issues, assisting in the development of solutions and approaches for successful team alignment.

• Participate in resource planning and management for new product development, sustaining product support, and sustaining projects.
• Collaborate with the divisional program management team, manufacturing sites teams, and design assurance team to ensure projects are clearly scoped, appropriately allocated, and aligned with divisional and company priorities.

• Participate in ongoing product/project support activities, including sustaining project management, complaint review boards, real‑time aging review boards, and design review committees.
• Monitor the efficacy of design control and risk management processes and competency of personnel, identifying areas for improvement and building consensus on improvement initiatives.
• Sponsor and coordinate improvements to established procedures and initiate new procedures as needed.

• Accountable for risk management within the context of post‑market surveillance, ensuring Risk Management files are up to date and Health Risk Assessments are initiated where appropriate.
• Oversee Health Risk Assessments in evaluating on‑market products, ensuring efficient and effective analysis of situations, including problem definition and benefit‑risk profile consistency.
• Promote awareness of design controls, user requirements, risk management, change control, and verification and validation processes across R&D and new development teams.

• Bachelor’s Degree in a technical engineering field.

• 12 years of experience with a Bachelor's Degree or 10 years with a Master’s Degree.
• Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive.
• Familiarity with ISO 14970, IEC 60601, IEC 62366, and EN 62304.
• Experience managing multi‑source demands for project and product support, fostering an effective team environment.
• Experience with Oracle or Agile is beneficial.

• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Thorough knowledge of Root Cause Methodologies, Risk Management, Lean Manufacturing, Kaizen, Kanban, Poka Yoke, and visual factory ideology.
• Strong working knowledge of verification and validation requirements…