- Design and Development of customer-focused sterile and non-sterile medical devices, across multiple locations, from concept through to commercialization, project managing technical elements of development projects
- Carry out project activities within a Design Controls Framework in accordance with ISO 13485 & 21CFR820 Quality Systems
- Problem-solving activities & ideas generation to deliver practical solutions
- Support for design for manufacturing
- Generating work/test plans, design documentation (including specifications); Development & Validation of new test methods, etc.
- Developing and maintaining good working relationships with all key internal and external organizational stakeholders (RA, QA, Clinical, Operations)
- Liaise with other business functions to effectively execute projects
- Bachelor's Degree in Science and/or Engineering (or equivalent)
- Experience working within the Medical Devices or equivalent regulated industry
- Experience in medical device design control and/or manufacturing processes
- Demonstrable experience of on-time delivery of complex technical projects and activities
- Building productive relationships with external parties ( design houses and contract development and manufacturing organizations (CDMO's)
- Applying a range of statistical techniques incl. Design of Experiments (DoE) for product/process development activities
- Highly structured, ability to progress tasks in parallel, and proven problem-solving skills
- Experience of Product & Process Validation activities
- The ability to communicate effectively in English (verbal and written) is essential
- Highly computer literate Microsoft Office (Outlook, Excel, Word, and PowerPoint)
- Experience in product design (high level and detailed), detailed engineering design, quality function deployment, design for manufacture, design for assembly, and/or value proposition design
- Experience in Advanced Wound Care
- Experience with materials, adhesives, processing flexible films/fabrics, and antimicrobials
- Bachelor's Degree in Science and/or Engineering (or equivalent)
- The candidate should also be flexible as travel may fall outside normal working hours
- Flexibility to support Operations across shifts and weekends if required.
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R&D Development Engineer - Deeside, United Kingdom - ConvaTec
Description
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 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visitPosition Overview
ConvaTec Development Engineer has experience in medical device product development and manufacturing processes and is part of a team supporting the maintenance of existing products in the market. The Development Engineer will work cross-functionally to help solve design issues, and manufacturing issues, support on-market complaints, and support the delivery of line extensions.
Key Responsibilities
Skills & Experience
Desirable
Qualifications/Education
Principal Contacts & Purpose of Contact
The nature of this role will require the individual to deal with a wide range of contacts at different levels of seniority within the organization. In addition, the individual will deal with contacts external to the organization where these may be external companies or government agencies.
Internal – RA (to understand and work with regulatory guidance for medical devices); Operations (to support and guide and articulate design aspects to device manufacture); QA (to work through quality-related issues and provide solutions)
External – Test houses (develop testing and test methods); manufacturers (support multifunctional teams on design-related aspects)
Travel Requirements
Up to 10% (variable and dependent on projects).
Languages
Fluency in English. Additional languages are nice to have.
Working Conditions
Hybrid working – 2 days per week in the office driven by business requirements as Convatec has a flexible approach to office working.
Special Factors
Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But stretch yourself and embrace the opportunities, and you could make your biggest impact yet.
This is stepping outside of your comfort zone.
This is work that'll move you.
#LI-MF1
#LI-Hybrid
Beware of scams online or from individuals claiming to represent Convatec
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.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at .
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.
