Senior R&D Engineer Catheters (m/f/d)

Contract Medical International GmbH HRdirekt; Dresden; Presencial; EUR 78.000 - 110.000; Jornada completa

Descripción de la vacante

Heraeus Medevio in Germany seeks a technically seasoned engineer to lead catheter/interventional device development from concept through manufacturing transfer. You will work in cross-functional teams across engineering, RA/QA, and program management to deliver safe, compliant devices.

Required are a Master-eligible degree in a relevant field and 5+ years in medical device development, with hands-on experience in catheter design, materials, and manufacturing processes. Travel may be occasional.

Formación

• Bachelor’s degree in biomedical engineering, mechanical engineering, plastics engineering, or a related field, preferably master’s.
• Minimum of 5 years of relevant professional experience in the medical device development environment.
• Proven experience in developing catheters or interventional devices with design-to-manufacture focus.
• Knowledge of ISO 13485 / FDA 21 CFR Part 820 and 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.

Responsabilidades

• Lead technical design for catheters and interventional devices from concept to manufacturing transfer.
• Collaborate with cross-functional teams including program managers, design and process development engineers, prototyping technicians, and RA/QA.
• Structure development projects and form high potential teams.
• Ensure design-to-manufacture (DfM) alignment and regulatory compliance.
• Develop and build prototypes for safe and effective use.
• Develop test methods for bench testing, design verification, and simulated use validation.
• Maintain engineering documentation under design control and keep stakeholders informed.

Conocimientos

DOE

Tolerance analysis

Minitab

Intercultural teamwork

Data-driven decisions

Educación

Biomedical/Mechanical/Plastics Eng, Master preferred

Herramientas

Extrusion

Thermoforming

Laser processing

Descripción del empleo

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

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.

Any further questions?

Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: [e-mail]. Or visit us at jobs.heraeus.com;).