R&d Engineer Ii, Product Development

R&D Engineer II, Product 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 Engineer II (Product Development) CRM, reporting to the Director R&D CRM and working closely with the Project Leader, participates in R&D projects which includes the following tasks: the translation of market requirements into technical requirements, design development, introduction of technologies, design verification, as well as the coordination of production introduction including process optimizations, product validation and product approval.

He/she will be participating in R&D projects running within several sites and will have international cooperation’s. He/she will execute policies, processes, methods and generate documentation according to existing standards in order to maintain common standards across the sites.The R&D Engineer CRM establishes and maintains effective communication with project team members globally, manufacturing and quality department, management and other stakeholders.

**Your Responsibilities**
- Develop a product and qualify and integrate new technologies and materials through the understanding and utilization of extensive technical knowledge and on the basis of specifications in compliance with the external standards, internal rules, design rules and internal requirements (ie. Marketing, production, economic or qualitative requirements) in accordance to the project plan
- Ensure quality in a product’s design for usability, reliability, functionality, marketability and manufacturability
- 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
- Develop new tests to test new product requirements; Analyze data using statistical techniques and communicate results to a cross-functional team
- Analysis and evaluation of product complaints
- Conduct risk assessment of the product and the product components. Participation in the risk assessment of the production processes of the product
- Provide technical expertise or support related to manufacturing
- Train production personnel in new or existing methods.
- Prepare reports by collecting, analyzing and summarizing information and trends
- Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives of finished products together with the manufacturing and quality department
- Ensure that standard operating procedures, company policies and procedures are adhered to
- Ensure safe work procedures are followed, maintain a safe work environment

**Your Profile**
- Bachelor’s Degree in Electrical, Mechanical or Industrial Engineering or equivalent
- At least 3-5 years of work experience in R&D, product development, process / production engineering preferable in the medical device industry
- Expertise in the development of medical products and approval processes in an international environment
- Experience with manufacturing processes, automation and methods
- Experience working within a quality and design controlled environment and familiar with ISO13485 and GMP
- Knowledge in the verification and validation of medical devices
- Proficient in Project Management
- Strong aptitude for hands-on engineering testing and experimentation in a lab environment
- Ability to demonstrate time management and leadership 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

Location: Singapore | Working hours: Full-time

Job ID: 60377 | 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.