Director, Device Development

Role Overview

• 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 committees, and executive reviews (e.g., Board, TechOps, CMC).
• Shapes device strategy narratives for leadership audiences, translating technical complexity into clear risk, readiness, and decision frameworks.
• Drives alignment on what BRT must own internally vs. leverage externally, enabling scalable development and industrialization models.
• Accountable for design control strategy and execution in accordance with BRT QMS and global regulatory expectations for combination products.
• Ensures design history file (DHF) integrity, robust V&V planning, and traceability across user needs, risk management, and performance requirements.
• Partners closely with Regulatory Affairs and Quality to support global submissions and associated efforts related to pre-clinical and clinical phases of development.
• Key contributor to design transfer to Bayer Product Supply, ensuring manufacturability, scalability, and global supply robustness.
• Shapes early phase clinical device strategy with commercial goals in mind, including supplier selection, design development and manufacturing site readiness to support clinical phases.
• Drives alignment across clinical, open‑label, and commercial device configurations, ensuring continuity and long‑term sustainability.
• Recognized internally as the go‑to authority for cell therapy device design and device strategy.
• Influences multiple programs and organizational capabilities, not just a single asset.
• Independently sets direction in areas of technical ambiguity, with decisions shaping program outcomes.
• Elevates the effectiveness of the broader device organization through mentorship, standards, and governance leadership.

Requirements

• Bachelor’s or Master’s degree or equivalent, or PhD with 10+ years of experience
• B.S. or M.S. in Biomedical, Materials engineering, or related and a minimum of ten years of medical product (preferably medical device or biologics) development and manufacturing experience. An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above may be considered.
• Thorough understanding of Design Controls and cGMP requirements compliant with ISO 13485 and the QSR (21 CFR Part 820)
• Significant experience in development and validation of medical device manufacturing processes and technologies is required
• Demonstrated cross functional leader with successful track record of delivering projects on time and within budget
• Experience with biologic product delivery (delivery media, bio-polymers, delivery technologies, micro-fluidic control, anatomy) is a strong plus.
• Experience leader in delivering products through IND
• Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint, Project)