R&D Engineer (iLP)

R&D Engineer (iLP)

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, CRM is responsible for effectively supporting of the product and process developing and qualification of new products and processes (ie. Automated assembly methods, welding of different materials). The R&D Engineer, CRM is furthermore responsible to create specifications for new components and new materials, to create and maintain manufacturing flow charts for new products, to maintain process specifications and to execute installation and operations qualifications (IQ & OQ). The R&D Engineer, CRM is responsible to establishes and maintains effective communication with the other R&D groups, the Operations CRM team, Quality department, Senior Management and other stakeholders.

This position could come with a partial stay in Berlin for training and supporting of current projects (at maximum 12 months).

Your Responsibilities

• 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.

• Improve manufacturing processes with focus on automation for new product development activities.

• Execute Installation and Operation qualifications.

• Ensure quality in a product’s design for usability, reliability, functionality, marketability and manufacturability.

• Develop internal technical capabilities and expertise related to manufacturing and technology for automated assembly.

• Support the product development through aspects of product design criteria, product function and customer needs, complaint assessments, animal studies and supplier contacts.

• Assess the feasibility of new product specifications and definition of specific product requirements in product specification.

• Support product design verification and validation taking design and production processes into consideration.

• Support the process development through aspects of process design criteria, process targets, process risks and mitigations

• Design and conduct experiments to demonstrate process feasibility and to establish essential engineering parameters for manufacturing processes with excellent process capabilities

• 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.

• Create purchasing specification of the materials and new 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.

• 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.

• Conduct risk assessment of the product and the product components. Participation in the risk assessment of the production processes of the product.

• 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

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 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

What we offer

• being encouraged to think and act entrepreneurially
• working in global teams and projects
• developing yourself professionally

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Singapore | Working hours: Full-time

Apply now under: www.biotronik.com/careers

Job ID: 45894 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.