Job Description

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:

• Bachelor’s degree in biomedical engineering, mechanical engineering, plastics engineering, or a related field, preferably master’s,
• 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.
  
  

ReqID: 59617