Senior R&D Engineer
Fresenius Medical Care is the world’s leading provider of products and services for dialysis by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day.
Our manufacturing plant in Palazzo Pignano specializes in producing bloodlines, operating around the clock with a dedicated workforce of more than 550 employees. Within this dynamic setting, our R&D departments play a pivotal role, ensuring that components and medical devices are correctly developed as per projects assigned in compliance with applicable regulations and internal procedures.
Tasks:
Define and document medical devices development according to internal procedures and Design Control requirements.
Develop new product concepts collecting and analyzing input from clinical, marketing, literature and other sources.
Review and/or define new product and component requirements.
Review and/or define new component specification.
Develop test methods and equipment/fixtures.
Coordinate technical team for the realization and preparation of bill of materials, verification of adequate components availability, verification of supplier capacity, coordination with production to evaluate feasibility.
Support Risk Manager in Risk management activities.
Release and review project documentation.
Generate intellectual property.
Support Product Interface documentation release acting Product Interface Manager role.
Support internal interfaces (Quality and Production department).
Support material procurement and shipping requests.
Monitoring of suppliers concerning status of project and dealing with technical issues.
Leading Product Development activities according to referenced standards (ISO 13485, ISO 14971, FDA 21 CFR 820.30) and internal procedures and DFSS (Design for Six Sigma).
Working closely in Cross Functional Team with both internal and external groups.
Support the preparation of the budget.
Provides assistance in calculating costs of component and finished product; propose and drives appropriate mitigation and contingency plan.
Profile:
Degree or similar education in bio-engineering/mechanical engineering discipline
7+ years of experience in a similar role
Basic in technical drawing
Basic knowledge of passive medical devices made in plastic materials
Basic knowledge about plastic materials and relative manufacturing and assembly technologies
DFSS (Design for Six Sigma)
English level B1
Minitab
Basic in technical drawing and computation analysis (es. CFD, FEA)
Microsoft Office suite (Excel, Power Point, Word)
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.