Senior R&D Engineer Catheters (mfd)

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

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 2200 employees worldwide together we will meet tomorrows 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:

• Bachelors degree in biomedical engineering mechanical engineering plastics engineering or a related field preferably masters
• 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.
  
  

Curious Apply now!

We are interested in finding the best candidates and they may come from a nontraditional background. So please dont hesitate to apply even if you arent an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio!

Any further questions

Our Recruiting Team Heraeus Medevio is happy to assist you by email: . Or visit us at .

Required Experience:

Senior IC

Employment Type : Full Time
Experience: years
Vacancy: 1