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 http://www.convatecgroup.com
Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us on our journey to #ForeverCaring as a Senior Digital Health Systems Engineer, and you’ll drive progress that really means something.
Convatec is seeking a highly motivated and skilled Senior Digital Health Systems Engineer to join Technoloy & Innovation Digital Solutions group. In this role, you will play a critical part in our mission to build pioneering trusted medical solutions to improve the lives we touch. On assigned projects, you will be the key interface between marketing, customers (patients/clinicians), internal clinical teams and the research & development team to ensure accurate, unambiguous and testable requirements for our digital health products, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and Machine Learning enabled Medical Device (MLMD) products. You will be also accountable for ensuring the end product meets the specified requirements.

SKILLS & EXPERIENCE:

• Proven expertise in working in a collaborative, fast-paced environment where the teams are multi-disciplinary.
• Excellent verbal and written communication skills.
• Extremely detail oriented. Need to set standard of quality for the team that ensures the products we ship have best-in-class customer experience.
• Expert on requirements definition. Working knowledge of requirement management tools (e.g. JAMA, Cockpit, DOORS, etc.) is preferred.
• Experience in Agile product development process is preferred.
• Working knowledge of cloud-based software application is preferred.
• Experience in system safety and risk analysis in a regulated environment including hazard analysis, fault-tree analysis, use risk analysis (UFMEA) and design failure modes and effects analysis (DFMEA).
• Has a positive can-do-attitude and inculcates the same among other team members.
• Has proven ability to work with geographically distributed teams and can work with teams with diverse background and experience.

QUALIFICATIONS/EDUCATION:

• Bachelor’s degree in Biomedical Engineering, Systems Engineering, Computer Science or Electrical Engineering or related fields. Master’s degree is preferred.
• 5+ years of product development experience in a regulated space, preferably in the medical device area. Lesser years of experience maybe considered based on education and professional experience.
• 3+ years experience working as a systems engineer

TRAVEL REQUIREMENTS

Position may involve travel up to 10% of the time, overseas travel is expected. Most trips will include overnight travel.
Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.
This is a challenge more worthwhile.
This is work that’ll move you.

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ForeverConvatec

• The overarching responsibility of this role is to ensure all systems engineering responsibilities are fulfilled on time with high quality on assigned projects.
• You will be responsible for translating high level user stories and voice-of-the-customer into system-level use cases and requirements that can be used as inputs by the research and development team.
• You will be expected to work with relevant stakeholders to accurately define personas for the product, and the patient and clinician journey map.
• You will work collaboratively with cross-functional teams to develop new product concepts, optimal design strategies and system architectures.
• You will be responsible for ensuring the system-level requirements are traced and aligned to the architecture and design.
• You will be responsible for maintain a healthy product, project and sprint backlog, with high-quality information and proper job-size estimate, following Agile princple.
• You will work with the UI/UX group to ensure things such as formative and summative studies are done at the right time and as per the process.
• You will be accountable for verification and validation, including User Acceptance Test (UAT).
• You will also be responsible for the system-level risk analysis, working with the design teams to ensure things such as DFMEA are aligned with the risks analysis.
• You will support the regulatory teams in regulatory submissions.
• You will work with the labelling teams to ensure they have the necessary inputs to create user manuals and other labels necessary for the product.