Job Description

About Convatec

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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com





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 more than 10,000 colleagues, we provide our products and services in around 90 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. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

About the role:

Support New Product Development as well as remediation projects across Infusion Care Business Unit and other BUs as required. Support improvement projects within Design Assurance Ensure effective Design Transfer of new products into production. Ensure compliance to EU ISO 13485, US 21CFR820, ISO 14971 and MDR and other applicable global Quality Management regulations.

Your key duties and responsibilities:

Leads key areas for the development of new products within the New Product Development process. Responsible for ensuring that Design Control requirements meet regulatory and applicable procedural requirements. Provides leadership as subject matter expert in Design Control and actively supports and influences development teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and in the execution of timely Design Reviews. Champions Risk Management activities through leadership, facilitation and active support during New Product Development activities. Demonstrates courage to drive Risk Management in decision making to determine sound and timely decisions that balance compliance, business, and product performance without compromising customer safety. Drive subject matter expertise of our Design Control process, as well as our Risk Management process to support the product documentation during all phases of NPD and/or remediation projects as required to support regulatory compliance and submissions. Review essential parts of the technical documentation to ensure adherence to the design control as well as risk management processes in product development projects o Act as a key figure in the planning and follow-up of all design control activities. Involved in all project activities, through review and approval to ensure compliance to our standard operating procedures and instructions as well as external standards and regulations. Involved in assessing, developing, and continuously improving the standard operating procedures, instructions, and templates, in the context of risk management and product development. Identifies and reports opportunities for improvement to peers and management. Manage improvement projects within Design Assurance, as well as coach and guide the team.. Participates in CAPA-projects, as well as internal and external audits as required. Takes responsibility for the measuring and monitoring of performance against agreed KPI.

Skills:

Preferable knowledge within in Medical Device product development (Class II) Demonstrated ability to effectively work and communicate in a cross-functional, multinational environment building cooperative working relationships. Demonstrated ability to work effectively with multi-cultural and diverse suppliers and contract manufacturers. Good interpersonal skills and ability to influence people without direct authority You communicate easily to achieve a common goal and at the same time deliver high quality and timely solutions and deliverables. You appreciate thoroughness and correctness as a natural focus of the daily work. Proactive and flexible in adapting to changing environment and able to manage and prioritize work and competing objectives. Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint.

Experience:

Extensive experience from a similar role as Design Control Engineer or Product Quality Engineer, in new product development or in remediation projects, driving the design control activities within a Medical Device company. Proven 5 years experiences as Design Assurance Engineer or similar. You may have worked in a maintenance of Quality Management System (QMS) process's role, looking after the process, as well as technical documentation preparation. Experience gained within a Regulated Industry, preferable Medical Devices. Demonstrated knowledge of Design Controls, Regulatory and GxP Compliance requirements such as QSR 21 CFR Part 820, EU MDR 2017-745, GMP Parts 210 and 211, and ISO 13485. Demonstrated knowledge and experience of Medical Device Risk Management ISO 14971 and the application and use of Risk Management tools such as Hazard Analysis, FMEA and Process Mapping. Experience with Quality tools such as Quality Control Plans, Test Method Validation and Transfer, Root Cause Analysis, Process Validation, Process Optimization. Practical experience of Notified Body audits and Regulatory Authority inspections.

Qualifications/Education:

Master's or bachelor's degree in engineering, pharmacy, technical science, or similar technical diploma in laboratory science.

Working Conditions:

This role may be based in the UK with a remote working structure.

Ready to join us?

At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.


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Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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