R&D Engineer II
3 months ago
R&D Engineer II (Software Development)
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 R&D Engineer II (Software Development), CRM is reporting to the R&D Process Development Lead. He/She is responsible for the design, development, maintenance and improvement of automated machines and test equipment including the integration with middleware and MES.
He/She is responsible for supporting new product development projects, establishing new automation and / or software applications and improving existing processes with the focus of manufacturability and automation. He/She is responsible for effectively developing and qualifying of new processes and applications including creation of specifications, qualification plans and execution of the respective qualification.
The R&D Engineer II (Software Development), CRM maintains effective communication with the other R&D groups, the Operations CRM team, Quality department, Senior Management and other stakeholders.
In view of the new process development activity, we would require the shortlisted candidates to be in Berlin, Germany for up to 1 Year.
Your Responsibilities
Work as part of agile teams to design, implement, and verify the equipment control/test software. Develop end to end automated machine, middleware, and MES integration/verification. Develop, maintain, and enhance automated test framework, tools, and tester. Documentation of requirements and coordination of enhancements in the assigned area. Involved in drafting of functional specifications and detailed design specifications. Lead and/or participate in cross-functional teams to support development/test projects. Document test system and software designs. Implement test plans, procedures, and generate reports. Perform verification and validation testing. Interpret requirements, identify design parameters, and ensure solutions are implemented accurately and within budget to meet project requirements and schedules. Develop new manufacturing processes with focus on automation for new product development activities.Liaise and interact with production department, operations, engineering, quality department and senior management and provide technical support and troubleshooting for existing processes.
Assist with internal and external audits.Your Profile
Masters/bachelor's degree in Electrical or Electronics / Communication Engineering with 5 years' experience in Software Development Experience in writing verification plans, test cases, defects reports, executing and managing test cases. Software test development experience with programming and scripting languages (C#, Type Script, shell script preferred) Strong technical ability and knowledge of test instrumentation devices such as signal generators, oscilloscopes, spectrum analyzers and power meters Advanced understanding of statistical data analysis, design margin principles, analog and digital measurement techniques, schematic capture skills and manufacturing processes Familiar with serial communication protocols and hardware – CAN, SPI, Ethernet, HERMES Familiar with SMEMA/SECS/GEM/OPC-UA Familiar with continuous testing, and related tools such as Jenkins or GitHub In-depth working experience in CE/FDA regulated industries will be an advantage. Experience in high-volume, high-tech manufacturing environment Experience working within a quality and design-controlled environment ie. ISO 13485/GMP will be an advantage Expertise in the development of medical products and approval process is preferred Project Management Experience preferred Ability to demonstrate time management skills Team player with strong organizational, interpersonal, communication and intercultural skills Creative, systematic with entrepreneurial mind setWhat we offer
being encouraged to think and act entrepreneurially working in global teams and projects developing yourself professionallyAre you interested?
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