R&D Engineer

The role:

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.

Key Responsibilities:

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 analysis3D 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 EHSEnsures 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

Authority (if applicable):

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

Skills & Experience:

Technical work-base experience

Logical thinking

Good communication skills

Good Time management

Team work experience3D CAD – Parts and Assemblies and simulation - experience2D Documentation – experienced

Injection molding process knowledge

Tolerance stack-up analysis – experienced

Advantage:

Plastic materials and polymers, their properties and usage for manufacturing - experienced

Design for injection molding and assembling process – experienced

Statistical techniques – experienced

Project management

Qualifications/

Education:

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’sLanguages

Speaking:
Yes
English Writing/Reading:  Yes
English Working Conditions (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

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.#LI-AN1#LI-Remote Beware of scams online or from individuals claiming to represent ConvatecA 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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