Director of Design Assurance – Medical Devices

Hologic; 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

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.