Innovative Process Development Engineer for Medical Devices
6 days ago
About BIOTRONIK SE & Co
As a leading manufacturer of cardio- and endovascular medical devices, we are headquartered in Berlin, Germany, and represented in over 100 countries by our global workforce.
Our committed team of highly specialized and exceptionally skilled employees drives crucial advancements in the world of cardiology, changing lives every day.
The Role
We are seeking a talented R&D Engineer II (Process Development) to join our CRM team. Reporting to the R&D Process Development Lead, you will be responsible for supporting new product development projects, establishing new process technologies, and improving existing processes with a focus on manufacturability and automation.
Your Responsibilities
You will develop and qualify new processes, including creating process specifications, qualification plans, and executing risk assessments. You will also maintain effective communication with other R&D groups, Operations, Quality, Senior Management, and stakeholders.
Your Key Tasks
- Research, develop, and integrate new technologies, processes, and materials based on extensive technical knowledge and compliance with external standards, internal rules, design rules, and project plan.
- Develop new manufacturing processes with a focus on automation for new product development activities.
- Design and conduct experiments to demonstrate process feasibility and establish essential engineering parameters for manufacturing processes.
- Develop basic design data, define operating conditions, critical limits, safety, and quality parameters for manufacturing processes through scale-up and modeling of unit operations.
- Ensure quality in product design and its processes for usability, reliability, functionality, capability, marketability, and manufacturability.
- Analyze and interpret experiment and manufacturing process data of materials and components.
- Collaborate with Operations to develop design criteria for new products and technology transfer from R&D to production.
- Execute risk assessment of the product, product components, and manufacturing processes.
- Define technical requirements for suppliers, source suppliers for special requirements, and provide technical support as needed.
- Liaise with Production, Engineering, Quality, and Senior Management to provide technical support and troubleshooting for existing products and process improvement.
Your Profile
To succeed in this role, you will have:
- A 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, preferably in the medical devices industry.
- Experience in high volume manufacturing and assembly processes and improvement methods.
- Experience in automation and digitalization.
- Expertise in the development of medical products and approval processes is preferred.
- Proficient in Project Management.
Benefits
Working at BIOTRONIK offers numerous opportunities for growth and professional development in a dynamic and innovative environment. We encourage entrepreneurial thinking, global teamwork, and personal growth.
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