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.

Job Summary

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.

Key Accountabilities

• 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.

Networking/Key relationships

• 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 (IEC32604)
• Senior Management/Stakeholders – Provides project metrics and insights while com-municating project impacts on business objectives

Minimum Knowledge & Experience required for the position:

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 have experience in a medical device field (or similar: pharma). Strong understanding of Medical Device Software Development (IEC 62304) is preferred. Experience with CE marking and FDA approval is strongly preferred.

Skills & Capabilities:

• Understanding of both Waterfall and Agile methodologies, with ability to tailor and implement hybrid approaches based on project needs
• Advance knowledge of Software Development Life Cycle (SDLC) processes in medical device development, with the ability to establish and optimize development processes
• Understanding and application of medical device standards, including IEC32604, with the ability to guide teams in compliance and risk management strategies
• Good communication and presentation skills, with demonstrated ability articulate complex technical concepts to diverse audiences, including senior management

Travel requirements:

This position requires minimal travel. Expect to travel approximately 5% annually. These trips will be for attending important team meetings/events where physical presence is beneficial for collaborative work sessions, or team-building purposes.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com