Senior Engineer - Research and Development

About the role:

Infusion care (IC) Senior Engineer– 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

• Develops and qualify test methods requires for design verification / validation process

• 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

• Managing projects / processes, working independently with limited supervision

• Coaching and reviewing the work of lower level professionals

Skills & Experience:

• Technical work-base

• 3D CAD – Parts and Assemblies and simulation

• 2D Documentation

• Plastic materials and polymers, their properties and usage for manufacturing

• Design for injection molding and assembling process

• Tolerance stack-up analysis

• Statistical techniques

• Logical thinking

• Good communication skills

• Good Time management

• Team work experience

• Project management experience

• Leading small teams 1-3 people

Qualifications/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 will involve travel, mostly within Europe (Denmark & UK) 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 - 8 days per month (+ 2 extra days in exceptional situations)

• Flexible working hours accordance with the local policy

Employee perks, benefits:

• Annual global incentive plan-bonus

• Large corporation with representation and manufacturing

• plants in the world

• Stable employer for Michalovce city and its surroundings

• Corporate culture – Underpinning everything we do are our values:

  • Improve care

  • Deliver results

  • Grow together

  • Own it

  • Do what´s right

• Home office possibilities

• Flexible working hours

• Introduction program according to company standards

• Development trainings

• Career opportunities for internal employees

• Referral bonus system

• Recognition program

• Meals in the amount of 0.44 Eur per one meal unit / day

• Supplementary pension plan after the trial period with the

• employer's contribution

• Social fund (various support and perks for employees)

• Free bus transport within Michalovce city

• Various events / team building activities for employees

• Various employee discounts by vendors within Michalovce city