Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit Convatec.
At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Software Verification & Validation Lead, and you’ll do the same.
Convatec is seeking a highly motivated and skilled Software Verification and Validation (V&V) Lead to join the Technology & Innovation Digital Solutions team. In this role, you will play a critical part in our mission to build pioneering trusted medical solutions to improve the lives we touch. You will lead all verification and validation activities in our digital innovation projects and drive the team towards our goal of zero-escaped defects. Working with a geographically dispersed cross-functional team, you will ensure that our medical software products - including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and Machine Learning enabled Medical Device (MLMD) - meet all requirements and deliver the intended value to our customers.
Key Responsibilities:
* Develop and implement comprehensive design verification and validation plans to ensure complete traceability between V&V tests and product requirements.
* Develop, review, execute and maintain test protocols, test cases, and test scripts to ensure software functionality and performance.
* Manage or coordinate internal or third-party test engineers to ensure on-time completion of V&V activities with high quality.
* Analyze test results to determine root causes, log defects and track to closure, contribute to defect resolution.
* Drive towards zero-escaped defects in verification & validation. Monitor defect trends during project lifecycle.
* Author, review and maintain design history files.
* Contribute to requirement definition and refinement, especially from the testability perspective.
* Contribute to product risk management, post-market change control.
* Support validation and qualification of third-party software components and tools.
* Stay up-to-date with industry trends in the software V&V. Provide guidance to the team on best practices. Contribute to process improvement.
* Interact with the cross-functional project team. Communicate plan, progress and issues clearly in a timely manner.
Skills & Experience:
* Working knowledge of relevant medical device regulations, standards, and guidelines, including IEC 62304 (Software Life Cycle Process), ISO 13485 (Quality Management System), ISO 14971 (Application of risk management to medical devices).
* Proficiency in software testing methodologies, automation tools, and frameworks.
* Familiarity with V&V best practices following Agile/Scrum development methodologies.
* Knowledge of testing of cloud and mobile-based products and testing for reliability and performance.
* Strong analytical and problem-solving skills with good attention to detail.
* Excellent writing and verbal communication skills.
* Collaborative mindset and strong interpersonal skills.
* Ability to manage competing priorities and deliver quality work with minimal supervision.
* Experience in biosensors, Artificial Intelligence/Machine Learning, electronics, and mechanics is a plus.
Qualifications/Education:
* Bachelor’s degree or higher in Computer Science, Software Engineering, or other related engineering fields.
* 5 or more years of experience in software verification and validation, of which a minimum of three (3) years in the medical device industry. Lesser years of experience may be considered based on education and professional experience.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
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