Director, Design Assurance

Mary Dickson; Newark (DE); Hybrid; USD 167,400 - 297,600; Full time

Job summary

Mary Dickson is seeking a Director of Design Assurance located in Newark, DE (Hybrid). This role entails strategic leadership, managing the Design Assurance team, and ensuring compliance with FDA regulations.

The ideal candidate will have a strong technical background, with at least 12 years of relevant experience in the field. Responsibilities include overseeing product development activities and promoting continuous improvement in design and quality processes.

A competitive salary range of $167,400 - $297,600 is offered, along with bonus eligibility, depending on qualifications and experience.

Qualifications

• 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.
• Experience managing multi-source demands for project and product support.

Responsibilities

• Direct the Design Assurance organization for new product development.
• Oversee the BSH Design Assurance team, ensuring goals are met.
• Promote awareness of design controls and drive continuous improvements.

Skills

Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards

Thorough knowledge of Root Cause Methodologies, Risk Management, Lean Manufacturing, Kaizen, Kanban

Strong working knowledge of verification and validation requirements

Proven ability to develop and manage high-performing teams

Lean-Six Sigma Green or Black Belt Certification

PMP Certification

Education

Bachelor’s Degree in a technical engineering field

Tools

Oracle

Agile

Job description

Director, Design Assurance

Location: Newark, DE (Hybrid).

Responsibilities

Strategic Leadership

• 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.

Team Management

• 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.

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 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.

Guidance and Oversight

• 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.

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

• 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.

Qualifications

Education

• Bachelor’s Degree in a technical engineering field.

Experience

• 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.

Skills and Certifications

• 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 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 managers, supervisors, and 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.
• Lean‑Six Sigma Green or Black Belt Certification is beneficial.
• PMP Certification is beneficial.

Compensation

The annualized base salary range for this role is $167,400 - $297,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Equal Opportunity Employment

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.