Senior R&D Engineer, Catheters

Darum lohnt es sich

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.

Proven ability to lead technical projects and collaborate effectively within cross‑functional teams. #J-18808-Ljbffr Core Competencies Demonstrates expertise in the development of interventional devices, particularly catheters, with a strong focus on design control, regulatory compliance, and prototype development.