Associate Director, Device Development

Responsibilities

• Lead highly visible cross-functional project teams in developing complex delivery device and combination product technologies with the goal of clinical introduction, commercialization, and post marketing support.
• Partner with key stakeholders like CMC teams, asset teams, quality, regulatory, external operations and other functions.
• Lead external device vendor engagement and strategic oversight of externally developed device technologies.
• As a device team leader, drive the design, development, verification, validation, and transfer of combination products and medical devices.
• Lead product and process improvement related to on market products.
• Work closely with contract manufacturers to ensure quality and timely delivery of project deliverables.
• Prepare and present reports to senior management on project status, risks, and opportunities.
• Mentor engineers and scientists within the department.

Requirements

• Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices.
• Demonstrated ability to manage cross-functional teams and collaborate effectively with stakeholders.
• Firsthand experience with parenteral drug delivery with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable.
• Deep expertise in design controls.
• Experience working with contract manufacturers.
• Exposure to human factors engineering.
• Experience working with regulatory agencies and ensuring compliance with industry standards.
• Effective communication skills and demonstrated ability to influence up, down, and across multiple levels and functional areas (corporate wide).

Skills

• Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices.
• Firsthand experience with parenteral drug delivery with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable.
• Deep expertise in design controls.
• Experience working with contract manufacturers.
• Exposure to human factors engineering.
• Experience working with regulatory agencies and ensuring compliance with industry standards.
• Effective communication skills and demonstrated ability to influence up, down, and across multiple levels and functional areas (corporate wide).

Education

• Bachelor’s degree in engineering, Life Sciences, or a related field.
• Advanced degree preferred.

Contact

• Device engineers, device quality, device regulatory, external manufacturing, drug product formulation scientists, supply chain engineers, asset team members like clinical and commercial.

Onsite, Remote, or Flexible Hybrid

Hybrid. 3 days a week in Novato

Travel Required

Up to 10% domestic and international travel

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

• Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems.
• Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.