R&d Engineer Ii

R&D Engineer II (Process 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 (Process Development), CRM is reporting to the R&D Process Development Lead. He/She is responsible to support new product development projects, to establish new process technologies and to improve existing processes with focus of manufacturability and automation.

He/She is responsible for effectively developing and qualifying of new processes, including creation of process specifications and process qualification plans and execution of process risk assessments. The R&D Engineer II (Process Development), CRM maintains effective communication with the other R&D groups, the Operations CRM team, Quality department, Senior Management and other stakeholders.

**Your Responsibilities**
- Research, develop, qualify and integrate new technologies, processes and materials through the understanding and utilization of extensive technical knowledge on the basis of specification in compliance with the external standards, internal rules, design rules and internal requirements (ie. production, economic or qualitative requirements) and project plan.
- Develop new manufacturing processes with focus on automation for new product development activities.
- Develop internal technical capabilities and expertise related to manufacturing and technology for automated assembly.
- Design and conduct experiments to demonstrate process feasibility and to establish essential engineering parameters for manufacturing processes with excellent process capabilities
- Develop basic design data, define operating conditions and critical limits, and establish safety and quality parameters for manufacturing process through scale up and modeling of unit operations
- Ensure quality in product’s design and it’s processes for usability, reliability, functionality, capability, marketability and manufacturability
- Execute and document analytical evaluation of the materials and components. Analyse and interpret experiment and manufacturing process data of the materials and components
- Analyze data using statistical techniques and communicate results to a cross-functional team
- Utilize technical expertise to design and develop complex new test methods and equipment
- Collaborate with operation team to develop design criteria for new product and new technology transfer from R&D stage to production
- Execute risk assessment of the product, the product components and the manufacturing processes in collaboration with Product Development, Operations and Quality Department.
- Define the technical requirements for suppliers. Sourcing for suppliers for special requirements. Provide technical support to suppliers as and when required.
- Plan project costs and ensure compliance with the planned project costs.
- Design layout of equipment or workspaces or optimize the production flow to achieve maximum efficiency.
- Liaise and interact with production department, operations, engineering, quality department and senior management and provide technical support and trouble-shooting for existing products and process improvement.
- Train production personnel in new or existing methods.
- Assist with internal and external audits.
- Keep abreast of latest developments in process technology. This includes injection moulding, extrusion, assembly, packaging and sterilization. Research new processes or materials processing technologies for possible new product development

**Y**our Profile**
- Bachelor’s Degree in Mechanical or Industrial Engineering, Material Sciences or equivalent
- At least 2-3 years of relevant work experience in Research & Development, product design and development, Manufacturing and Process Engineering Management in preferable the medical devices industry
- Experience in high volume manufacturing and assembly processes and improvement methods
- Experience in automation and digitalization
- Experience with manufacturing processes of thermoplastic polymers, silicon and metals
- Experiences in analytic methods of these materials
- Experience working within a quality and design controlled environment ie. ISO 13485/GMP will be an advantage
- Strong attitude for hands-on engineering testing and experimentation in a lab environment
- Expertise in the development of medical products and approval process is preferred
- Knowledge in the verification and validation of processes and medical devices
- Proficient in Project Management
- Ability to demonstrate time management skills
- Team player with strong organizational, interpersonal, communication and intercultural skills Creative, systematic with entrepreneurial mind set

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