Senior R&D Engineer Catheters (mfd)

The following challenges await you:

• You work in many areas of interventional devices including access devices advanced diagnostic and therapeutic catheters and complex delivery systems applying state-of-the-art technology.
• In your role you are the technical lead in development projects for catheters and other interventional devices with a customer-specific design from concept freeze throughout product design and manufacturing transfer to the manufacturing sites.
• You work in cross-functional teams with program managers design and process development engineers prototyping technicians documentation specialists and RA/QA representatives within the global footprint of our company as well as with our business partners and customers.
• You support the project managers to structure development projects forming high potential teams.
• You take over responsibility for the technical design and for meeting specification and performance requirements with a strong focus on design-to-manufacture (DfM).
• You develop and build prototypes - draft and hands-on - designed for safe and effective use to improve the well-being of patients worldwide.
• You develop test methods for bench testing design verification and simulated use validation
• You ensure complete engineering documentation according to regulations standards and industry best practices under design control using office documents and our paperless PLM system.
• You keep stakeholders customers and others informed of the project status and upcoming issues.
• You guide and mentor less experienced team members
  
  

Your profile:

• Bachelors degree in biomedical engineering mechanical engineering plastics engineering or a related field preferably masters
• A minimum of 5 years of relevant professional experience in the medical device development environment
• Proven experience in developing catheters or other interventional devices (e.g. through projects patents publications) and in-depth knowledge of catheter design and materials as well as related manufacturing technologies (e.g. extrusion thermoforming laser processing) with a focus on design-to-manufacture
• Knowledge of design control and regulatory requirements according to ISO 13485 / FDA 21 CFR Part 820 and other applicable catheter standards
• Experience with design and process risk management (FMEA) design verification and simulated use testing
• Ability to make data-driven decisions utilizing statistical tools such as DOE tolerance stack-up analysis or Minitab
• Experienced worker in interdisciplinary and intercultural teams (e.g. quality regulatory affairs production) including mentoring of team members
• Good command of English both written and spoken
• Structured solution-oriented working style with a high level of personal responsibility
• Able to travel occasionally to customers study locations or other company sites throughout the world.