At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Manager – Research and Development Engineering, and you’ll do the same.
The Infusion care (IC) Manager – Research and Development Engineering is a member of global R&D team with responsibility for Product and Process development of Infusion Care products, their introduction to production and their Life Cycle Management.
Key Responsibilities:
Manages the activities related to Design control process and change control process following all relevant CvT standards and procedures.
Manages the remediation of technical documentation for regulatory compliance.
Leads a team to deliver key IC projects following IC business strategy and priority, e.g new product introduction, design changes on products, material changes, cost reduction activities, resilience projects, Corrective and Preventive Actions (CAPAs) relating to product design and packaging design, new test method development.
Evaluates requirements of new project or resources; estimate realistic time to completion.
Prioritizes resource deployment in alignment with stakeholders’ priorities and overall business impacts.
Represents R&D for Infusion Care in the change control (CCR) and CAPA processes.
Develops, communicates, and holds the team accountable to high standards of timeliness and quality of work.
Develops annual budgets and headcount plans and manage within them.
Develops clear and concise reporting of the team’s activities, priorities, and project statuses, and develop a cadence of regular communication to stakeholders.
Ensures all required feasibility work, analysis, validation, testing, and trials are performed on time and to the required Quality and Regulatory standards, as well as in line with ConvaTec procedures and processes.
Maintains a working technical knowledge of a broad range of manufacturing processes and materials areas relevant to the Infusion Care product range.
Develops and maintain strong, collaborative working relationships with all key internal and external organizational stakeholders.
Develops R&D team and continuously works on its improvements and improvements of working environment.
Improves capability of R&D team by technical strengthening of the skills and experiences and by infrastructure and equipment as well.
Follow CvT principles for behavior and values and influences dedicated team for their following.
Follows all CvT internal standards for EHS.
Skills & Experience:
Experience working within Medical Device or equivalent regulated industry in an Engineering-biased role
Experience working with relevant processes and technologies at core of ConvaTec infusion products (e.g. injection molding, adhesives, welding technologies, plastics)
Excellent communication, problem solving and analytical skills
Ability to understand business and operational objectives and prioritize high volume and complex workloads accordingly
Logical thinking
Experience with product and process validation activities
Acts with a sense of urgency and take appropriate actions in conditions of uncertainty
Knowledge of requirements of FDA's QSR, GMP and ISO 13485 or similar regulations
Understanding / awareness of EU Regulation of Medical Devices 2017/745 (desirable)
Ability to communicate effectively in English (verbal and written) is essential
Good computer skills Microsoft Office (Outlook, Excel, Word, and PowerPoint)
People management and leadership skills
Qualification/Education:
University, technical degree or Science degree (physic or chemistry) preferred
Design Control in accordance with EU ISO 13485 & US 21CFR820 Quality Systems for Medical Devices preferred
Educated in CvT internal design control, change control, risk management and another applicable SOP’s and WI’s
Travel Requirements:
Position may involve travel, mostly within Europe but international travel may be expected within 10% of working hours. Some trips may include overnight travel
Working Conditions:
Work in office environment, production centers and laboratory
Office based position with home office possibilities based on the local home office policy
Flexible working hours accordance with the local policy
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
#LI-AC2
#LI-Hybrid
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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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