Director, Device Development

As part of Blue Rock Therapeutics vision to change the future of medicine by enabling ground‑breaking cell therapies, the candidate will be a leader in the combination device development and manufacturing team responsible for ensuring that the company’s leading cell product candidates have an appropriately designed, tested and implemented combination device. Key elements include procedures to prepare and administer cell products compatible with current clinical technologies and practice of medicine, and medical device systems that safely, and accurately deliver these products to meet the unmet needs of patients with intractable diseases.

The Device Development team works with leading physicians and other experts to develop clinical product procedures, delivery systems and other technologies in close partnership with our cell product development colleagues. The successful candidate is a proven team leader in the development and manufacturing of cutting‑edge medical product technologies including combination medical devices and ancillary products. The ideal candidate has a deep understanding of medical device development processes and regulations, is comfortable working directly with world‑renowned physicians, is highly familiar with design and manufacturing technologies and has a demonstrated track record of leading product development teams that have taken concepts and advanced them into clinical evaluation and commercial launch utilizing internal and external capabilities.

Collaboration with a highly motivated, world‑class team of engineers and scientists promises an exciting and engaging work environment for motivated, self‑starting candidates. Proven history in developing drug delivery device development is required; experience in combination product development and surgical device development is strongly preferred.

As a global technical and organizational leader, the Director of Device Development is responsible for end-to-end design, development, transfer, and clinical readiness of complex medical devices and combination products for BRT’s Cell Therapy portfolio. This role operates beyond individual project execution, providing strategic technical leadership, cross‑functional alignment, and governance‑level decision support across Device Development, Tech Ops, Quality, Regulatory, Clinical, and New Product Planning organizations.

The role is a recognized authority in device design, design control, and industrialization, and functions as a primary integrator between BRT internal teams and external device partners (e.g., CDMOs, suppliers, analytical labs), ensuring clinic readiness and compliance from development through clinical studies and eventual handoff to parties responsible for commercialization.

• Acts as technical representative on project teams for complex delivery and preparation device systems, spanning system, device, and component levels.
• Defines and maintains technical strategy, design intent, and risk profile across development phases, from early development through clinical phases and handoff to those with ownership for launch and commercial sustainment.
• Provides expert judgment on material selection, key quality target product profile, usability, manufacturability, and design trade‑offs, particularly for cell therapy combination products (drug delivery, dose preparation, accessories, etc.).

• Leads cross‑functional collaboration across Device Development, TDT, Quality, Regulatory, Supply Chain, Commercial and Bayer stakeholders.
• Serves as primary escalation point for device‑related technical and executional issues, resolving ambiguity and enabling timely decision‑making.
• Coaches and mentors senior and mid‑level engineers, strengthening technical depth, decision quality, and design control rigor across the organization.
• Liaises with Bayer Device stakeholders to align approaches and maintain a network of internal and external device technical SMEs.

• Represents device engineering at program governance forums, steering…