In this lead role you will manage and support analysts within the Physical Testing department (Scientific and Technology Laboratories COE) to play a pivotal role in ensuring the operational effectiveness of the laboratories and support the new product development of Ostomy and Continence Care products from the Ostomy and Continence Care Business Units. Key aspects of this role include carrying out R&D project design control activities, utilising your experience of diverse techniques and methodologies and maintaining the highest lab safety and regulatory standards. The Research Advisor, will be expected to work closely with personnel across the Scientific and Technology Laboratories Centre of Excellence and the wider Technology & Innovation group.
Key duties and Responsibilities
Working as a member of the physical testing department for the Ostomy and Continence Care franchises of ConvaTec.
Management and Leadership of a group of scientists and assistants.
Experience and practical knowledge of 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 (time, budget and resources)
Carry out Research and Development project activities within a Design Controls Framework in accordance with ISO 13485 & 21 CFR 820 Quality Systems
Plan and coordinate laboratory testing and training activities for Continence Care and Ostomy, internal only.
Ensure competence of all personnel performing laboratory activities.
Resolve ideas and problems to reality through testing and/or simulation techniques.
Have a diverse lab bench analysis knowledge using diverse techniques and methodologies.
Ensure lab safety and respond to laboratory emergencies. Maintain working knowledge of health and safety procedures/ regulations
Maintain appropriate laboratory metrics to assess and measure activities performance.
Coach and mentor team members.
Generating and updating Standard Operating Procedures (SOP’s) work/test plans, design documentation (including specifications); Development and validation of new test methods etc.
Developing and maintaining good working relationships with all key internal/ external stakeholders.
Liaise with other business functions to effectively execute Laboratory activities.
Degree or equivalent in Science/ Technical/ Engineering
Significant working and testing in a suitably regulated laboratory environment
Understanding of applied statistics in method/ product/ process development
Experience gained within a Regulated Industry, preferable Medical Devices/ Pharmaceuticals
Management and coaching of team members.
Bachelor’s Degree in Science and/or Engineering (or equivalent)
Experience working within the Medical Devices or equivalent regulated industry.
Experience in laboratory environments, test method development, validation, analysis, statistics, design of experiments, and various analytical measurement techniques.
Demonstrable experience of on-time delivery of complex technical projects and activities
Building productive relationships with external parties, e.g. design houses, test labs, and contract development and manufacturing organizations.
Knowledge of Design Control Frameworks in accordance with EU ISO 13485 and US 21 CFR 820 Quality Systems for Medical Devices.
Highly structured, ability to progress tasks in parallel, with proven problem-solving skills.
Highly computer literate i.e. Microsoft Office (Outlook, Excel, Word and Powerpoint).
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.
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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