R&D Engineer

Convatec; Manchester; On-site; GBP 42,000 - 62,000; Full time

Job summary

Convatec Infusion Care R&D team in the United Kingdom is seeking an Engineer to drive the design and development of new products, components and materials. You will manage change control and maintain regulatory-compliant documentation while collaborating across global teams.

You will develop test methods for verification and validation, conduct root-cause analyses, and contribute to IP generation while ensuring alignment with ISO 13485 and FDA 21 CFR 820 standards.

Qualifications

• Demonstrated experience and understanding of Design Control is essential.
• Ability to manage multiple projects simultaneously across diverse teams is essential.
• Engineering discipline knowledge in Systems/Mechanical/Design Engineering is essential.

Responsibilities

• Design and develop new products, components and materials per Design Control SOPs.
• Perform changes on existing products following Change Control SOPs.
• Authors, updates, reviews and approves documents for Design Control and Risk Management.
• Develops and qualifies new test methods for Design Verification and Process Validation.

Skills

Design Control

Project management

English communication

Multi-project handling

Education

Degree in Systems/Mechanical/Design Engineering

Tools

SolidWorks

FMEA

Ishikawa

5 Why

Job description

The role:

Infusion Care R&D Engineer responsible for Customer Projects, New Product Development, and Life Cycle Management of Infusion Care products.

Key Responsibilities:

• Design and development of new products, components and materials following SOPs for Design Control, in compliance with regulatory demands.
• Perform changes on existing products, components and materials following SOPs for Change Control, in compliance with regulatory demands.
• Authors, updates, reviews and approves documents associated with Design Control and Risk Management for R&D.
• Develops and qualifies new test methods for Design Verification and Process Validation.
• Participates in CAPA and NC investigations and provides technical assessment for design related issues.
• Owns root cause investigations associated with product design and the implementation of corrective or preventive actions.
• Collaborates across the organisation and supports colleagues to achieve shared goals and objectives globally.
• Clearly communicates technical data cross-functionally, making proposals and recommendations based on analysis of this data.
• Proactively engages with key stakeholders to manage expectations and delivers on project commitments.
• Maintains expertise by keeping updated on engineering advancements through publications, patents, university/industrial contacts and vendor discussions.
• Identifies and generates new Intellectual Property (IP) and evaluates the existing IP landscape.
• Generates concepts and creates and updates 2D/3D models, assemblies and engineering drawings in CAD software (SolidWorks).
• Considers Design for Manufacturing and Design for Assembly methodologies to develop robust designs, suitable for manufacturing processes.
• Maintains compliance with the QMS and completes all required training on time.
• Maintains compliance with Health, Safety, and Environment standards.
• Follows all Convatec values and behaviours.

Authority (if applicable):

• Review and approval/rejection of all documents where R&D involvement is needed and where a higher level of authority is not required.
• Make decisions for product design, development and design changes.
• Make recommendations for appropriate action in case of product design related issues.

Skills & Experience:

• Demonstrated experience and understanding of Design Control is essential.
• Ability to effectively manage and prioritise multiple project workloads, working simultaneously across numerous diverse project teams is essential.
• Demonstratable experience in an engineering discipline with knowledge of Systems and/or Mechanical/Design Engineering is essential.
• Ability to use CAD software packages, preferably experience with SolidWorks is desirable.
• Working understanding of ISO 13485 and 14971 standards, and FDA 21CFR820 is desirable.
• Experience performing Root Cause Analysis (RCA) and utilising RCA tools e.g. 5 Why, Ishikawa Diagrams, FMEA is desirable.
• Comfortable working remotely with general supervision.
• Ability to communicate effectively in English (verbal and written) is essential.

Qualifications/Education:

• Qualified to degree level in a relevant STEM related subject, preferably Systems, Mechanical or Design Engineering.

Principal Contacts & Purpose of Contact

Internal – R&D Engineers, Senior R&D Engineers, Senior Managers R&D, Project Managers, and other Core Team members (e.g. Advanced Operations, Artwork and Labelling, Regulatory, Design Assurance etc.) to execute projects and resolve product and process related issues.

External – Suppliers and Test Houses to obtain and provide relevant information to execute projects and resolve product and process related issues. Customers to provide status updates on ongoing projects.

Travel Requirements

Position may involve travel up to 10% of the time, mostly within Europe but overseas travel is expected. Most trips will include overnight travel.

Languages

• Speaking: Yes English
• Writing/Reading: Yes English

Special Factors

Convatec is a multi-national company, therefore a degree of flexibility in the working day may be required when working with non-UK based colleagues.

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.

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 over 10,000 colleagues, we provide 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, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 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.