Distinguished Scientist, Autoinjector Platform

Job Description

We are seeking a highly experienced and skilled Distinguished Scientist to join our Device Development & Technology (DD&T) organization to serve as a senior technical subject matter-expert and advisor for our Autoinjector platform. This role’s scope and accountability will encompass the entire lifecycle from early development through lifecycle management, providing critical technical strategic oversight and guidance across all teams involved in the development and support of Autoinjectors. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.

Primary Responsibilities:

• Technical Strategic Oversight:

  • Provide deep subject matter expertise in the design, development, and manufacturing of 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 complex investigations into technical challenges related to design, manufacturing, and scale-up processes, employing advanced material science principles to resolve issues effectively.  Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to investigations and resolutions.

• Cross-Functional Collaboration:

  • Act as the primary technical advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance, regulatory, and manufacturing teams across the CMC ecosystem. Key collaborative and influential partnerships span across multiple stakeholders and organizations within our Research and Development (R&D) and Manufacturing divisions.

  • Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance, accountability, and innovation.

• Lifecycle Management and Technical Transfer:

  • Oversee lifecycle support for Autoinjector products, including performance monitoring, design optimization, and process validation. Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to lifecycle management.

  • Manage a broad scope of technical transfer activities related to the introduction of new Autoinjector products from development to manufacturing, ensuring robust introduction, qualification, and performance monitoring.

• Regulatory Compliance:

  • Collaborate closely with R&D and Manufacturing 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. Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to regulatory submissions and audits.

• Innovation and Continuous Improvement:

  • Stay abreast of industry trends, emerging technologies, and best practices in Autoinjector 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 performance qualifications against industry standards.

  • Encourage the exploration of problem solving in innovative ways to achieve technical and business results. Personally drive and model technical rigor in expectations and actions.

• Mentorship and Development:

  • Provide mentorship, coaching, and guidance to junior engineers and cross-functional teams, fostering a culture of technical excellence and innovation.

  • In partnership with senior leadership, enable the growth and technical, scientific, an operational strength of the talent pipeline.

  • Promote knowledge sharing, technical excellence, and best practices within the organization, ensuring that technical expertise is disseminated effectively.  Inspire a learning culture and drive deep technical understanding.

Minimum Education Requirements – One of the following:

• BS/BA degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related disciplines, with a minimum of 20 years of hands-on experience in medical device engineering, with a focus on Autoinjectors or combination products.

• MS/MA degree in Biomedical Engineering, Me