Software Project Lead

Country

United States

Shift

1st

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

The Software Project Lead is accountable for overall schedule, execution, and completion of the project. Responsibilities span across the life-cycle of a software project, including planning, scheduling, execution, documentation, metrics, and delivery of the project. In addition to project responsibilities, the project lead also facilitates the team, oversees the people performing work on the projects, and ensures regulatory compliance. The project lead is the representative of the software team in cross-functional core team activities.

This role drives on time project completion and ensures adherence to regulatory requirements at the project level facilitating software submissions.

• Planning, facilitating, and tracking development projects across distributed teams that will be deploying high quality software for medical device software across multiple product ranges using Agile or Waterfall framework.
• Establishing and maintaining the technical documentation, ensuring that regulatory requirements for IVD medical devices are specified and kept up to date
• Drive cross-functional collaboration, particularly focusing on regulatory and customer needs, while fostering effective stakeholder relationships
• Promote servant-leader culture, facilitate and be accountable for identifying and re-moving impediments for the team, define and track project metrics, and be an Agile Subject Matter Expert for all products using the Agile framework
• Communicating effectively verbally and in writing, including conveying technical in-formation to technical and non-technical teams.
• Partner with Quality Management and Research and Development to monitor stand-ards and guidance documents related to IVD medication device regulatory profiles, identify gaps and areas to improve processes and procedures, and supervise the documentation processes related to regulatory compliance.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Development Team (Scrum Master Role) – Facilitates Agile ceremonies, removes impediments, coaches on Agile practices, and promotes continuous improvement in development processes
• Product Management/Product Owners – Develops strategic alignment between devel-opment initiatives and product vision, ensuring the developing product is in sync with the product roadmap
• Quality Assurance and Regulatory Teams – Ensures adherence to quality standards and medical device compliance requirements (IEC
  32604)
• Senior Management/Stakeholders – Provides project metrics and insights while com-municating project impacts on business objectives

Education:

Bachelor’s degree in Computer Science, Software Engineering, Computer Engi-neering, or related technical field.

Experience:

5+ years of related working experience in developing and/or testing complex software projects, including 2+ years of project or program management experience with direct Software Development Life Cycle for Application on Instrument software. Must…