Director, Device Development

Director, Device Development

1. Position Summary:

Lead and manage the Device Development Team within Pharmaceutical Development in the commercial development and manufacturing of an intravitreal injector to deliver a sustained release implant for use in the treatment of retinal diseases. A technical expert in drug delivery devices who can navigate and balance complex engineering, regulatory, quality, and commercial needs. Provide direction to staff and collaborate with cross-functional team members to design and implement plans in harmony with corporate goals and timelines. Oversee and manage injector commercial scale development activities in partnership with our external contract manufacturer to assure operational compliance with global quality and regulatory standards. Communicate with executive level management to present program status on device development, critical path, risk, resources, budget, and timeline to gain alignment of strategy to meet production objectives.

1. Principal Duties and Responsibilities include the following:

1. Provide direction to Device Development engineers in the commercial planning, development, optimization, and scale up of an intravitreal injector to deliver a sustained release hydrogel implant currently in Phase 3 clinical studies.
2. Manage the ongoing and commercial scale-up injector development activities at our external contract manufacturer to ensure compliance with industry best practices, quality, and regulatory standards.
3. Effectively manage device development team meetings including scheduling, agendas, minutes, and action items, and ensure employees have clear, actionable, and measurable objectives in alignment with project and company goals.
4. Supervise the management of design history files and technical dossiers for combination products, including risk assessments, human factors usability studies, specifications, design control documents, test methods, and engineering protocols and reports.
5. Collaborate closely with all team members to ensure that project requirements, deadlines and schedules are on track.
6. Develop plans, budgets, and resource needs to meet project goals.
7. Deliver presentations on project status at various core cross-functional and leadership governance meetings and communicate decisions and direction to team members.
8. Review, develop, and generate combination product testing plans, data, specifications, and documentation to align with and support regulatory submissions.
9. Develop Technology Transfer Plan through life cycle phases to commercial launch including registration stability, product performance qualification, process verification and validation.
10. Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, and container closure systems.
11. Maintain in depth knowledge of global device and drug/device combination product guidelines and policy regarding IND/CTA, NDA/MAA, agency background packages, and post-approval submissions/variations.
12. Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and collective problem-solving.
13. Define development plans, annual and career goals, and mentorship for each direct report.

1. Supervisory Responsibilities:

Supervise a small team of experienced medical device engineers.

1. Qualification Requirements:

• PhD (15 years), MS (20 years) or BS (25 years) in Mechanical, Biomedical, or related engineering discipline.
• Minimum of 15 years of experience in medical device or combination product engineering, with considerable experience in technical transfer, design, development, verification, validation, and program management.
• Proven record of leadership and strategic direction in the successful transfer of medical devices and combination products into manufacturing sites.
• Experience managing a team of scientists and engineers.
• Advanced knowledge of FDA, EMA and ICH, ISO regulations, and industry standards for drug/device combination products with expertise demonstrated in engineering, device regulatory, design controls, device quality systems, human factors usability engineering, and risk management for medical devices.
• Strong demonstrated application of current GMPs and Global Quality Standards to parenteral manufacturing, drug/device combination products, and packaging.
• Demonstrates strong technical proficiency, writing and presentation skills and is able to translate technical information to non-technical audiences.
• Experience in sustained release formulations, tyrosine kinase inhibitors, and ophthalmic indications is a plus.
• A diligent, passionate about science and engineering, leader and team player that can effectively collaborate in a dynamic, cross-functional team environment.

1. Knowledge/Skill:

• Knowledge of medical device and/or pharmaceutical product development practices and regulatory requirements.
• Knowledge of safe laboratory practices.
• Able to drive projects through to completion.
• Excellent multi-tasking and prioritization skills.
• Friendly interpersonal skills.

1. Working Conditions:

• Work in both a laboratory and an environmentally controlled GMP environment.
• Limited travel to contract manufacturing sites when necessary.