Job Information
About the Position
Introduction
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.
Overview
This position focuses on activities related to the implementation, monitoring and maintenance of Application Lifecycle Management (ALM) support tools as a medical device manufacturer.
Key processes to be covered by such tools are software requirements definition and management, software change and configuration management, software project planning with focus on agile planning and work item management, quality management of our software solutions including defect management and risk management.
Other key aspects this position should be concerned with are the provision of data for reporting and KPIs, support to map the development process workflow, integration with version control tools, support for wikis and collaboration tools, and any possible integration with other ALM tools.
Governance and validation of these tools with a focus on our specific intended use, along with the proper generation of records demonstrating that the tool meets the required standards for medical device development, are also an important part of this function.
Responsibilities
Key Accountabilities
- Responsible for implementing the company's QMS in ALM tools.
- Coordinate with the QA Department and Solution Leaders to implement and maintain alignment of Solutions project control with the QMS as both evolves over time.
- Coordinate with other departments to meet other ALM needs.
- Administer users and licences for ALM tools.
- Lead the execution of the validation of the tool to ensure and demonstrate (with records) that the tool meets the required standards for the development of medical devices.
- Oversee, in coordination with other IT departments, infrastructure (IaaS) or services (SaaS) related to ALM tools, managing vendors when necessary.
- Apply defined strategies to reduce maintenance efforts by harmonizing concepts among projects.
- Participate in Werfen-wide initiatives for ALM tool governance and evolution strategies.
Networking/Key relationships
- This position requires cooperating with all project teams to know at all times the actual status of ALM needs and initiatives and work with them to introduce ALM changes and improvements.
- This position also requires tied cooperation with IT department to coordinate IT hosting and networking required in the deployment of ALM solutiions.
- In addition, it also works with external ALM service providers to increase the specialization and quality of the services provided.
Qualifications
Minimum Knowledge & Experience required for the position:
- Education: Engineer BS or MS, Computer science BS or MS, or other technical degree.
- Experience: A minimum of 3 years as an ALM specialist.
- Additional Knowledge:
- Language: Spanish, English
- Excellent understanding of Agile methodolgies.
- Desirable:
- Knowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971,..).
- Solid Knowledge and experience working in Medical device software life cycle process (IEC 62304)
- Experience in JIRA, Confluence and JAMA.
Skills & Capabilities:
- Good level of Technical and Conversional English.
- Team player with ability to work independently.
- Excellent interpersonal skills, good judgment and analytical skills.
- Effective time management and organizational skills
- Problem-solving attitude.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
www.werfen.com