Terumo Blood and Cell Technologies - Littleton, CO

posted about 1 month ago

Full-time - Senior
Littleton, CO

About the position

The Director of Application Software Engineering is responsible for leading the global Application Software Engineering team to achieve the company's business objectives. This role involves developing strategies to optimize project delivery and development processes, ensuring compliance with industry standards, particularly in .Net applications, and fostering a culture of collaboration and innovation across multiple global sites.

Responsibilities

  • Provide strategic leadership and direction to a globally distributed Application Software Development team, ensuring alignment with company objectives and industry best practices.
  • Lead and optimize the performance of cross-functional software development teams across multiple global sites, fostering a culture of collaboration, innovation, and continuous improvement.
  • Develop and execute short and long-term planning processes that establish technical objectives, project priorities, and milestones for business unit projects.
  • Oversee the entire software development lifecycle, ensuring that all products meet FDA and global regulatory requirements specific to medical software.
  • Manage budget, resource allocation, and project timelines across multiple development sites, including cost estimation, staffing decisions, and risk management activities.
  • Evaluate and implement proposed solutions, adaptations, and modifications to globally used software products, driving innovation and product improvement.
  • Establish and maintain best practices for software development processes, Design Controls, and Quality Management Systems across all development sites.
  • Drive the growth and development of the global software engineering team through individualized guidance, training, and supervision.
  • Collaborate with Quality Assurance, Regulatory Affairs, and other cross-functional teams to ensure compliance with industry standards and company policies.
  • Identify and evaluate new product opportunities and emerging technologies, articulating value propositions and potential risks to senior management.
  • Manage customer expectations and requirements across various regions, overseeing system change processes and coordinating release schedules and features.
  • Champion change initiatives and drive cultural alignment across the global organization.

Requirements

  • B.S. degree in Engineering required, preferably in computer science, software or mathematics.
  • M.S. or PhD degree in Engineering combined with management degree preferred.
  • Minimum 12 years of progressive experience developing Software products, with 7 years in a management capacity.
  • Experience in medical device software development is strongly preferred.
  • Hands-on software development experience, particularly with .Net applications.
  • Experience with program and project management methods and tools in a globally distributed environment.
  • Strong leadership traits with proficiency in .Net, Azure, Kubernetes, and cybersecurity.
  • History of developing technology and people leadership in a distributed team environment.
  • Documented involvement in process excellence across multiple development sites.

Nice-to-haves

  • Experience with FDA regulatory and ISO requirements affecting medical device software.
  • Strong interpersonal and conflict resolution skills, with the ability to manage across cultures and time zones.

Benefits

  • Health insurance
  • 401k
  • Paid holidays
  • Flexible scheduling
  • Professional development opportunities
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