Senior R&D Engineer

8 hours ago

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

BIOTRONIK, a leading manufacturer of cardio- and endovascular medical devices, is seeking a highly skilled R&D Senior Engineer to join its Process Development team. As a key member of this team, you will play a crucial role in driving innovation and improving manufacturing processes.

Key Responsibilities:
  • Support new product development projects and establish new process technologies to improve manufacturability and automation.
  • Develop and qualify new processes, including creation of process specifications and process qualification plans, and execute process risk assessments.
  • Maintain effective communication with other R&D groups, Operations, Quality, and Senior Management.
  • 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.
  • Research, develop, qualify, and integrate new technologies, processes, and materials.
  • 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 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 establish essential engineering parameters for manufacturing processes.
  • Develop basic design data, define operating conditions, and critical limits, and establish safety and quality parameters for manufacturing processes.
  • 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, and communicate results to a cross-functional team.
  • 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 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.
  • Design layouts of equipment or workspaces or optimize production flow to achieve maximum efficiency.
  • Liaise and interact with production departments, Operations, Engineering, Quality, and Senior Management, and provide technical support and troubleshooting for existing products and process improvement.
  • Assist with internal and external audits.
  • Keep abreast of 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.
Requirements:
  • 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, 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 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:
  • Encouragement to think and act entrepreneurially.
  • Working in global teams and projects.
  • Developing yourself professionally.

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