Director, Design Assurance

Director, Design Assurance

Are you a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic Director of Design Assurance to spearhead our Design Assurance organization, supporting new product development and sustaining activities for our Breast and Skeletal Health (BSH) products. This role is crucial in driving sustainable compliance, optimizing QMS processes, and fostering a culture of continuous improvement. We are located in Newark, DE and are open to hybrid presence.

Role is based in Newark, DE

What You'll Do :

• Strategic Leadership

Direct the Design Assurance organization to support new product development and sustain activities for BSH products.

Ensure the 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, 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

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 with managing multi-source demands for project and product support, fostering an effective team environment.

Experience with Oracle or Agile is beneficial.

Skills

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 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.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!

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.

Agency and Third-Party Recruiter Notice : Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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

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