Director, Design Assurance

Job Summary:

Hologic is seeking a highly experienced and motivated Director of Advanced Quality Engineering to lead our quality team in developing and maintaining high-quality, compliant medical devices. The successful candidate will be responsible for guiding new product development, supporting manufacturing-related design changes, and ensuring regulatory compliance. This role requires a dynamic leader who can build and manage a high-performing quality engineering team while collaborating with R&D, customers, suppliers, and various internal departments.

Key Responsibilities:

Strategic Leadership:

• Direct the Design Assurance organization to support new product development and sustain activities for GSS products.
• Ensure the appropriate organizational structure and personnel development to meet divisional strategies and goals.

Team Management:

• Lead the GSS advanced quality engineering team across various portfolio and locations.
• 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.

Quality and Compliance:

• 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.

Operational Excellence:

• 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 advanced quality engineering function, developing strategies and plans to meet current and future needs.
• Consult with stakeholders to understand and plan for business strategies and needs.

Guidance and Oversight:

• Provide guidance to the engineering team on design control compliance requirements, ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant.
• Address technical and project-based issues, assisting in the development of solutions and approaches for successful team alignment.

Resource Management:

• 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.

Ongoing Support and Improvement:

• 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.

Risk Management and Compliance:

• Oversee development of Risk Assessments for new product, 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.
• Lead usability testing for new product, and provide subject matter expertise for on-market product.

Physical Demands:

• Sit; use hands to finger, handle or feel objects, tools, or controls.

Qualifications:

Education:

• 12 years of experience with a Bachelor's Degree or 10 years with a Master’s Degree.

Required Skills:

• 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 with managing multi-source demands for project and product support, fostering an effective team environment.
• 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, Poke Yoke, and visual factory ideology.
• Strong working knowledge of verification and validation requirements for regulated products and requirements analysis, including developing testable and measurable specifications.
• Ability to assess product and project documentation as the principal advocate for compliance and effectively communicate assessments.
• Proven ability to direct individual contributors with varying experience levels across multiple products and projects.
• Ability to develop and manage high-performing, motivated, and engaged teams. Familiarity with employee development and mentoring processes.
• Demonstrates independent decision-making and prioritization, including resolving conflicts.

Beneficial Skills:

• Experience with Oracle or Agile.
• Lean-Six Sigma Green or Black Belt Certification.
• PMP Certification.