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R&D Senior Engineer (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 Senior Engineer (Process Development), CRM reports to the R&D Process Development Lead. He/She is responsible for supporting new product development projects, establishing new process technologies, and improving existing processes with a focus on manufacturability and automation.
He/She is responsible for effectively developing and qualifying new processes, including creation of process specifications, process qualification plans, and execution of process risk assessments. The R&D Senior Engineer (Process Development), CRM maintains effective communication with other R&D groups, the Operations CRM team, Quality department, Senior Management, and other stakeholders.
Your Responsibilities
- Oversee daily operations and tasks of the R&D Process Development Group and support the Process Development Lead.
- Lead internal process development projects to improve existing processes.
- Collaborate with external suppliers for process and software development.
- Lead external suppliers to provide automatic concepts and software solutions.
- Research, develop, qualify, and integrate new technologies, processes, and materials based on specification compliance with external standards, internal rules, design rules, and project plan.
- Develop new manufacturing processes with a focus on automation and AOI for new product development activities.
- Advise the process development team on developing new manufacturing processes with a focus on automation and AOI.
- Develop internal technical capabilities and expertise related to manufacturing and technology for automated assembly.
- Design and conduct experiments to demonstrate process feasibility and 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 processes through scale-up and modeling of unit operations.
- Ensure quality in product design and processes for usability, reliability, functionality, capability, marketability, and manufacturability.
- Execute and document analytical evaluation of materials and components.
- Analyze and interpret experiment and manufacturing process data of 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 the operation team to develop design criteria for new products and new technology transfer from R&D stage to production.
- Execute risk assessment of the product, components, and manufacturing processes in collaboration with Product Development, Operations, and Quality Department.
- Define the technical requirements for suppliers and source suppliers for special requirements.
- Provide technical support to suppliers as and when required.
- Design layout of equipment or workspaces or optimize the production flow to achieve maximum efficiency.
- Liaise with the production department, operations, engineering, quality department, and senior management to provide technical support and troubleshooting for existing products and process improvements.
- Assist with internal and external audits.
- Keep abreast of the latest developments in process technology, including injection moulding, extrusion, assembly, packaging, and sterilization.
- Research new processes or materials processing technologies for possible new product development.
Your Profile
- Bachelor’s Degree in Mechanical or Industrial Engineering, Material Sciences, or equivalent.
- At least 5 years of relevant work experience in process development, manufacturing, and process engineering management, preferably in the medical devices industry.
- At least 2 years of relevant work experience in the medical device industry.
- Experience in laser welding, automation, and dispensing systems including installation qualification (IQ) and operation qualification (OQ).
- 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.
- Experience in analytic methods of these materials.
- Experience working within a quality and design controlled environment, i.e. ISO 13485/GMP, will be an advantage.
- Strong hands-on engineering testing and experimentation capability in a lab environment.
- Expertise in the development of medical products and approval processes 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 an entrepreneurial mindset.
What we offer:
Being encouraged to think and act entrepreneurially, working in global teams and projects, and developing yourself professionally.
Are you interested?
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