Project Leader - 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 Global 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.

Goal of function:

Leads projects of medium-low complexity and assures the correct execution of activities for the development/optimization of components and finished products (disposable medical devices) to satisfy specifications and requirements of the products and guarantee the safety of the patients.

Assure the carrying out of the assigned work reaching the agreed targets in the respect of the company procedures and Policy (quality and safety standards).

Main tasks:

• Lead projects of medium-low complexity for the development/optimization of components/finished products for the blood purification of patients suffering from chronic or acute kidney failure (e.g. hemodialysis or peritoneal dialysis) including further blood purification treatments (e.g. apheresis) as assigned by the supervisor.

• Leads projects across all phases of planning, implementation, and production readiness (e.g.: concept development, design input/requirement definition, design verification and validation, design output release, design transfer, project release and implementation) based on defined design change or development process also supported by electronic system (e.g. Windchill).

• Worldwide execution of product sustaining projects in Value Stream area of competence with the goal of optimization and maintenance of existing products.

• Define and update product requirements and input for the respective product group.

• Define and update design output (e.g. technical specifications of the components and finished product).

• Support Product Interface documentation release acting as Product Interface Manager.

• Lead and support Design Transfer activities.

• Coordinate technical aspects and activities related to implementation in production of new products (bill of materials, verification of availability of proper components, verification of supplier capacity, discussion with production department to verify feasibility).

• Works autonomously on problems of moderate scope where analysis of data requires evaluation of identifiable factors.

• Exercises judgment within defined procedures and practices to determine appropriate actions under limited supervision.

• Set-up and drives cross-functional teams (R&D, Industrialization, Manufacturing, technology, purchasing, regulatory affairs, etc.) for the implementation of the individual project tasks.

• Organize Change Detailed Impact Assessment sessions with key stakeholders. Create, optimize, and drive structured schedules and project plans. Set and meet project milestones and deadlines effectively keeping plans on schedule.

• Monitor project progress based on coordinated project plans and report within the Value Stream Product Lead and to other project stakeholders.

• Anticipate, identify, document and manage key project risks; propose and drive appropriate mitigation and contingency plans.

• Collaborate across all the functional areas (R&D, I Marketing, QA, RA, Medica Department, Operations, and others) necessary to ensure successful project completion and delivery.

• Manage risk assessment and mitigation process for assigned projects with all key stakeholders.

Required training and education:

• Master's degree or similar education level in biomedical engineering/mechanical engineering discipline.

• Project management training or qualifications is desirable.

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Technical/Product knowledge:

• Must be proficient in the use of Project management tools and techniques to develop schedules, allocate resources, and track progress.

• Deep technical knowledge about requirements and characteristics for disposable Medical Device design, development and manufacturing.

• Basic in technical drawing.

• Basic knowledge about plastic materials and relative production- and assembly technologies.

Personal skills:

• Leadership skills and experience leading high-performing technical teams.

• Effective written and oral communication skills.

• Takes accountability for and delivers consistent decisions, actions, and results.

• Ability to take decisions in difficult situations.

• Builds effective relationships with core and extended team members and functional managers.

Languages:

• English (level B2).

IT skills:

• Minitab

• Very good command of Microsoft Office Suite (Excel, Power Point, Project, Visio, Word).

• Basic understanding of 3D CAD modelling principles and techniques, basic experience in CAD modelling, knowledge of 2D constructive mechanical drawing.

• SAP (basic knowledge).

Required professional experience:

• Minimum 3 years of experience in project lead/management.