Senior R&D Engineer, Catheters

Responsibilities

• Work in many areas of interventional devices
• Apply state-of-the‑art technology in development projects for catheters and other interventional devices
• Be the technical lead in development projects with a customer‑specific design
• Collaborate in cross‑functional teams with program managers, design and process development engineers, and other stakeholders
• Support project managers in structuring development projects
• Take responsibility for technical design and meeting specifications
• Develop and build prototypes for safe and effective use
• Develop test methods for bench testing, design verification, and simulated use validation
• Ensure complete engineering documentation according to regulations and standards

Requirements

• Bachelor’s degree in biomedical engineering, mechanical engineering, plastics engineering, or 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
• In‑depth knowledge of catheter design and materials as well as related manufacturing technologies
• 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 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.

Core Competencies

Demonstrates expertise in the development of interventional devices, particularly catheters, with a strong focus on design control, regulatory compliance, and prototype development. Proven ability to lead technical projects and collaborate effectively within cross‑functional teams.