Product and Process Development Project Lead, CRM

Product and Process Development Project Lead, CRM

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 Product and Process Development Project Lead, CRM is responsible for effectively managing strategic research and development projects involving implantable CRM leads and accessories, as well as the associated project team to support the Business Unit CRM (BU CRM). Product development includes 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 in accordance to the road map of the BU CRM.

The Product and Process Development Project Lead, CRM establishes and maintains effective communication with the departments R&D, Product Marketing and Regulatory Affairs of the BU CRM, the Operations CRM team, Quality department, Purchasing department, Senior Management and other stakeholders.

**Your Responsibilities**
- Act as a project leader for the R&D project team on development projects, project planning to carry out assigned responsibilities in a timely, diligent, safe and professional manner
- Support Company’s intellectual property strategy by documenting data, independent and patentable ideas that results from experimentations and concept generation activities
- Provide leadership in design analysis regarding functionality, design, material selection and manufacturing processes
- Lead the research and development to qualify and integrate new technologies 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
- 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
- Assess the feasibility of new process and inspection technologies with focus on automated or at least hands-off processes
- Lead 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
- Risk assessment of the product and the product components. Participation in the risk assessment of the production processes of the product
- Define the technical requirements for suppliers. Sourcing for suppliers for special requirements. Provide technical support to suppliers as and when required
- Plan the project costs and ensure compliance with planned project costs
- Assist with internal and external audits
- Ensure proper design and development documentation
- Create new SOPs and maintain all relevant SOPs to ensure strict compliance of R&D functional operation
- Keep abreast of latest developments in process technology. This includes moulding, assembly, packaging and sterilization, all joining technologies, cleaning, inspection and as well automation including pick and place and transportation between separate manufacturing steps. Researches new processes or materials processing technologies for possible new product development

**Y**our Profile**
- Bachelor’s Degree in Electrical, Mechanical or Industrial Engineering or equivalent
- At least 5 years of relevant work experience in Research & Development, product design and development, Manufacturing and Process Engineering Management in medical devices industry
- Experience in high volume manufacturing and assembly processes, improvement methods, particularly injection molded parts and assemblies
- Knowledge of engineering and production process concepts such as extrusion, plastic injection moulding, thermal processing polymer and automated assembly methods
- Experience working within a quality and design controlled environment ie. ISO 13485 will be an advantage
- Expertise in the development of medical products and approval process
- 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 demo