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.
Dimensions:
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.
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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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
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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.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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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.
Skills Required
- Relevant STEM degree, preferably in Systems, Mechanical, or Design Engineering
- Engineering experience with knowledge of systems and/or mechanical/design engineering
- Ability to use CAD software packages
- SolidWorks experience
- Working knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820
- R&D experience in the medical devices industry and Design Control
- Experience with root cause analysis tools, including 5 Why, Ishikawa diagrams, and FMEA
- Effective written and verbal communication in English
What We Do
At Convatec, #ForeverCaring is our promise to patients & healthcare providers, as we deliver pioneering trusted medical solutions to improve the lives we touch.
