Equipment Designer, R&D

Equipment Designer, R&D

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Equipment Designer, R&D, reports to the lead R&D Process Development. The Constructing Engineer is responsible for conception and construction of equipment and attends the constructional implementation and acceptance of the manufactured equipment. He / she will be responsible for the implementation of equipment related specifications, to create, own and maintain construction drawings. The Equipment Designer, R&D is in charge to plan and to execute machine risk analyses and to finalize equipment instances and to evaluate conformity. He / she will contribute to the definition of the equipment specifications, to the plan of the respective acceptance criteria and to support the setup of the calibration accordingly. He / she will execute policies, processes, methods, and generate documentation accordingly to existing standards in order to maintain common standards across the sites. The Equipment Designer, R&D establishes and maintains effective communication with project team members globally, manufacturing and quality department, management and other stakeholders.

Your Responsibilities

• Responsible for detailed mechanical design, including sizing of motors, sizing, design, and selection of drive train components, design of custom mechanical components, technical analysis, cost analysis, thermal management, cable management, detailed mechanical drawing creation, specification of appropriate fabrication methods, assembly, and test of the product.
• Owns machine designs through all phases of the project life cycle, from concept feasibility, through design and test, transfer to manufacturing, and support for field and manufacturing escalations.
• Develop and implement strategies to automate manufacturing processes and operations.
• Collaborate with cross-functional teams to identify opportunities for automation, process improvements, and maintain automated systems.
• Conduct risk assessments with cross functional team to identify potential process risk.
• Oversee the testing, commissioning, and ongoing maintenance of equipment´s and systems.
• Manages automation projects & system modifications, ensuring that verification & validation procedures are implemented.
• Ensure compliance with all relevant safety and regulatory standards.
• Participate in validation activities, including IQ / OQ / PQ (Installation Qualification / Operational Qualification / Performance Qualification) protocols and documentation.
• Provides assembly feasibility (Design for Manufacturability) and equipment cost estimates (CAPEX) to the new product development team.
• Provide training and support to production staff on the use of automated systems.

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