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R&D Engineer II
3 weeks ago
Requisition ID
60278
- Posted - Posting Country (1) - Work Location (1) -
Engineering
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Unlimited
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Full-time
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Professionals
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BIOTRONIK
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 II (Process Development), CRM is reporting 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 the creation of process specifications, process qualification plans, and execution of process risk assessments. The R&D Engineer II (Process Development), CRM maintains effective communication with other R&D groups, the Operations CRM team, Quality department, Senior Management, and other stakeholders.
Your Responsibilities
Research, develop, qualify, and integrate new technologies, processes, and materials through the understanding and utilization of extensive technical knowledge based on specifications in compliance with external standards, internal rules, design rules, and internal requirements (i.e., production, economic or qualitative requirements) and project plan.
Develop new manufacturing processes with a focus on automation 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 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 its 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 operations team to develop design criteria for new product and new technology transfer from R&D stage to production.
Execute risk assessment of the product, product components, and manufacturing processes in collaboration with Product Development, Operations, and Quality Department.
Define the technical requirements for suppliers. Source suppliers for special requirements. Provide technical support to suppliers as needed.
Plan project costs and ensure compliance with the planned project costs.
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 troubleshooting for existing products and process improvement.
Train production personnel in new or existing methods.
Assist with internal and external audits.
Keep abreast of the latest developments in process technology, including injection molding, 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, 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 analytic methods of these materials.
Experience working within a quality and design controlled environment (i.e., 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 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.
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:
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.
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