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R&D Process Development Engineer

2 months ago

Singapur, Singapore BIOTRONIK Full time
R&D Engineer II (Process Development)

At BIOTRONIK, we are seeking a highly skilled R&D Engineer II (Process Development) to join our team. As a leading manufacturer of cardio- and endovascular medical devices, we are committed to innovation and excellence in our products and processes.

Your Responsibilities
  • Develop and qualify new processes, including creation of process specifications and process qualification plans, and execution of process risk assessments.
  • Establish new process technologies and improve existing processes with a focus on manufacturability and automation.
  • Collaborate with cross-functional teams, including R&D, Operations, Quality, and Senior Management, to ensure effective communication and project delivery.
  • Design and conduct experiments to demonstrate process feasibility and establish essential engineering parameters for manufacturing processes.
  • Develop and maintain technical capabilities and expertise related to manufacturing and technology for automated assembly.
  • Ensure quality in product design and processes for usability, reliability, functionality, capability, marketability, and manufacturability.
  • Execute and document analytical evaluation of materials and components, and analyze and interpret experiment and manufacturing process data.
  • Utilize technical expertise to design and develop complex new test methods and equipment.
  • Collaborate with the Operations team to develop design criteria for new products and new technology transfer from R&D to production.
  • Execute risk assessments of products, product components, and manufacturing processes in collaboration with Product Development, Operations, and Quality Department.
  • Define technical requirements for suppliers, source suppliers for special requirements, and provide technical support to suppliers as needed.
  • Plan project costs and ensure compliance with planned project costs.
  • Design layout of equipment or workspaces or optimize production flow to achieve maximum efficiency.
  • Liaise and interact with production department, operations, engineering, quality department, and senior management to 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.
  • Stay up-to-date with the latest developments in process technology, including injection molding, extrusion, assembly, packaging, and sterilization, and 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 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.
  • Experience with manufacturing processes of thermoplastic polymers, silicon, and metals.
  • Experience in analytical methods of these materials.
  • Experience working within a quality and design-controlled environment, such as ISO 13485/GMP.
  • 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, and entrepreneurial mindset.
What We Offer
  • Opportunity to think and act entrepreneurially.
  • Working in global teams and projects.
  • Developing yourself professionally.