Lead Software Verification PDM

LivaNova; Mirandola; In loco; EUR 50.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading company in healthcare innovation is seeking a Software Verification Manager to oversee the verification processes for their Perfusion Data Management Platform. The ideal candidate will ensure compliance with medical regulations while leading their verification team with a focus on quality and continuous improvement.

Competenze

• Proven experience in software testing for desktop applications and complex systems.
• Hands-on experience in medical device software verification including standards such as IEC 62304.
• ISTQB Foundation certification is preferred.

Mansioni

• Define and support the verification strategy for software functionalities.
• Accountable for the growth and effectiveness of the software verification team.
• Ensure compliance of verification practices with medical regulations.

Conoscenze

Leadership

Problem Solving

Agile Methodologies

Software Requirements Engineering

Network Security

Cybersecurity Principles

Formazione

Master’s degree in Computer Science, Biomedical Engineering, Software Engineering or equivalent

Strumenti

Azure DevOps

JIRA

Descrizione del lavoro

Join us today and make a difference in people's lives!

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Shape the future of healthcare software through quality, leadership, and innovation

The Software (SW) Verification Manager is accountable for the Verification stream of the Perfusion Data Management Platform and peripherals for Functional, non-functional and Automation streams, in this role s/he is accountable for the whole Verification strategy and processes to ensure high standard quality of the SW, compliance with Medical Regulations and constantly improved practices.

In his/her role, the Lead SW Verification is responsible for :

• Support the definition of the process for Requirement design to ensure proper coverage and testability of the SW functionalities
• Define Verification strategy for Functional, non-functional Requirements
• Define the Test Automation strategy,
• Define and support SOPs for SW verification to ensure that state-of-the-art processes are in place
• Accountable for the SW Verification team growth in competencies, capabilities and effectiveness and talent management
• Participate to the Core Team, as discipline leader to report status, highlight challenges and provide insights
• Define reports templates for upper management for effective communication of status, risks
• Ensure compliance of the Verification practices with regulation
• Interact with other discipline functional manager to ensure sustainability and consistency of SaMD processes for SDLC

The following skills shall characterize an adequate profile :

• Master’s degree in Computer Science, Biomedical Engineering, Software Engineering, or equivalent technical discipline
• Proven experience in software testing for desktop applications and complex, distributed systems, ideally in regulated environments such as healthcare or medical devices
• Previous experience in leadership positions with proven report, problem solving, assertiveness and agile capabilities
• ISTQB Foundation certification
• Strong knowledge of software requirements engineering, with the ability to review, validate, trace, and contribute to high-quality specifications
• Proven track record of creating and maintaining comprehensive test plans, test cases, and traceability matrices covering functional, non-functional, UI, integration, and regression testing
• Experience using Azure DevOps, JIRA, or similar platforms for test planning, execution, defect tracking, and continuous integration
• Solid understanding of IT infrastructure, network security, and cybersecurity principles, such as firewalls, proxies, access control, TLS/SSL, and endpoint protection
• Required hands-on experience in medical device software verification, including standards like IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR Part 11
• Passionate for working in a multicultural environment and with strong commitment and orientation to the results

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

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