Director​/Senior Director, Device Development

Director/Senior Director, Device Development

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At Avalo (ahh-vah'-low), we’re 100% focused on developing treatments for immune‑mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL‑1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders.

Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.

We are seeking a highly experienced and skilled Device engineer to join our CMC organization and serve as a senior technical subject matter expert and advisor for Avalo’s combination products programs with a focus on prefilled syringes and autoinjectors to support biologics. This role’s scope and accountability will encompass the entire lifecycle from early development through lifecycle management, providing critical technical strategic oversight and guidance in the implementation and commercialization of combination products.

The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, development, manufacturing, testing, commercialization, and regulatory aspects supporting the validation and commercialization of combination products.

• Provide deep subject matter expertise in the design, development, assembly, and manufacturing of combination products (prefilled syringes and autoinjectors), ensuring compliance with industry standards and regulatory requirements (e.g., ISO 13485, FDA regulations). Actively seek out, anticipate, and solve significant scientific and technical challenges.
• Lead investigations at third party manufacturers through technical challenges related to design, manufacturing, and scale‑up processes, to resolve device and assembly issues timely and effectively.
• Act as the primary technical advisor for Avalo working on combination products (prefilled syringes and autoinjectors), fostering collaboration among Avalo and third‑party manufacturers in the engineering, quality assurance, regulatory, and manufacturing teams across the CMC roles. Key collaborative and influential partnerships span across multiple stakeholders and organizations.
• Oversee and manage CDMO relationships related to design and development activities for device combination products. This includes working with CDMO to develop the DHF and all required documents (i.e. PRD, DIR, V&V matrix, Risk Management, Design Reviews and Design Transfer) and support of technology transfer efforts for the final drug product assembly.
• Interface with external suppliers and partners to ensure the quality and compliance of components used in combination products (prefilled syringes and autoinjectors), driving performance, accountability, and innovation.
• Oversee lifecycle support for combination products, including performance monitoring, design optimization, and process validation.
• Manage a broad scope of technical transfer activities related to the introduction of new combination products from development to manufacturing, ensuring robust introduction, qualification, and performance monitoring.
• Collaborate closely regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing technical documentation for regulatory submissions and audits.
• Ensure that all engineering activities adhere to relevant regulatory standards and industry best practices.
• Analyze and interpret results and methods, troubleshoot processes, generate solutions to problems and meet related regulatory requirements.
• Stay abreast of industry trends, emerging technologies, and best practices in combination product technology, providing and championing recommendations for continuous improvement and innovation.
• Champion initiatives for design enhancements and supply chain expansions, ensuring that components meet their intended use and…