Senior R&D Engineer, Catheters

Jobtailor; Dresden; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor in Dresden seeks an experienced engineer to lead interventional device development, focusing on catheter design and regulatory compliance. The role requires steering technical projects, mentoring teammates, and delivering robust prototypes.

You'll collaborate with program managers and development teams, apply advanced testing methods, and ensure documentation aligns with standards while meeting customer specifications.

Qualifikationen

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

Aufgaben

• 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

Kenntnisse

Catheter design

Design controls

FMEA

Design verification

Simulated use testing

Data-driven decisions

Mentoring

English proficiency

Travel readiness

Interdisciplinary teamwork

Ausbildung

Bachelor's degree in biomedical engineering

Master's degree preferred

Tools

Minitab

Jobbeschreibung

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.