R&D Engineer

Infusion care (IC) Engineer II – Research and Development is a member of global R&D team with responsibility for Product development of Infusion Care products and their Life Cycle Management.

• Design and development of new products, components, materials or improvement of existing products, components or materials in accordance with customer requests and in compliance with actual regulatory demands following valid SOPs for Design Control
• Perform changes on existing products, components and materials following SOPs for change control process
• Makes decisions for design verification / validation plans and prepares adequate documentation
• Injection molding component remediation:

• Review of current drawing for molding components and reevaluation of critical dimensions
• Decision about tolerances on the base of Tolerance Stack Up analysis
• 3D models update
• Review and approval of injection molding validation documentation

• Performs technical assessment and provides technical support needed for decision of design related tasks
• Creates, updates, reviews and approves documents related to design control process and risk management where R&D involvement is needed
• Participates in projects to introduce new products or new changes on current products where R&D tasks have to be covered
• Participates for CAPA and NC investigations and provide technical assessment for design related issues and improvements
• Take ownership for investigation of root cause of issues associated with product design and for implementation of corrective or preventive actions following all relevant QMS principles and documents
• Cooperation and collaboration with all team members in cross‑functional teams
• Follows all CvT standard for values and behaviors
• Ensures compliance of all activities needed for product development or product changes with appropriate CvT standards and procedures
• Follows all CvT internal standards for EHS
• Ensures that work and task outputs are delivered at the required level and on time
• Continuously develops and improves the skills and experiences needed job execution

The Job Holder has authority to:

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

• Technical work‑base experience
• Logical thinking
• Good communication skills
• Good Time management
• Team work experience
• 3D CAD – Parts and Assemblies and simulation - experience
• 2D Documentation – experienced
• Injection molding process knowledge
• Tolerance stack‑up analysis – experienced

• Plastic materials and polymers, their properties and usage for manufacturing - experienced
• Design for injection molding and assembling process – experienced
• Statistical techniques – experienced
• Project management

• University, technical degree or Science degree (physic or chemistry) preferred
• Design Control in accordance with EU ISO 13485 & US 21
  
  CFR
  820 Quality Systems for Medical Devices preferred
• Educated in CvT internal design control, change control, risk management and another applicable SOP’s and WI’s

• Speaking:
  Yes English

• Writing/Reading:
  Yes English

(Applicable local workplace laws and statutes should be included in the description of working conditions)

• Remote position
• Flexible working hours accordance with the local policy

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,…