Senior R&D Engineer (2776)

Senior R&D Engineer

Do you want to be a part of Device R&D in our New Business Development area in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.

Every 2nd second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team!

Senior R&D Engineer in Device R&D

We offer a role where you will be part of the Device R&D team, where you will contribute to the development of new medical devices from the early concept phase to handover to production. You will collaborate closely with colleagues across departments and in addition to contributing to new development you will also be involved in providing technical support to Operation and Manufacturing for devices that are already in production.

Your role
You’ll represent Device R&D in NBD projects and play an active role in developing and documenting new device concepts. Key responsibilities include:

• Driving concept and prototype development for new devices
• Supporting Clinical Insights during user interviews
• Participating in requirement engineering and mechanical design for new devices
• Creating 3D/2D documentation, including tolerance chain calculations and measuring specifications
• Selecting materials and performing engineering feasibility studies for designed components and devices
• Continued engineering testing on the design during development to evaluate e.g.
  • Sterilization impact
  • Accelerated aging impact
  • Continued test and evaluation of design concepts towards RTM requirements
  • Design robustness evaluations
• Documenting testing in reports such as ETR’s (Engineering Test Report)
• Creating technical rationales, design considerations during development
• Assisting in test method development and preparing Design Control documentation for new devices
• Conducting Design for Manufacturing DFM evaluations and unit cost analysis in cooperation with other departments
• Taking part in Risk Management process/evaluation of new devices
• Acting as a technical partner for Project Managers and Supply Chain
• Collaborating with colleagues in Operations and Process Engineering

About you
As a person you are creative, relaxed, unformal, self-driven and thrive in an international environment where you will work closely with colleagues in both DK and PL. You have a structured approach when working and the ability to document your own work following local procedures and templates.

• You hold a Master’s degree in Engineering – preferably within Mechanics, Processes or Materials

• You bring a minimum of 5 years of experience from the Medical Device industry, preferably within device development or innovation
• You’re used to working with mechanical designs with manufacturing in mind and have hands-on experience with tools like SolidWorks and AutoDesk Inventor
• You thrive in an international, informal environment
• You’re structured in your work and can clearly document your contributions using local procedures and templates
• In addition, you’ll bring experience of familiarity with:

• 2D drawing and tolerance chain calculations
• GMP regulated environments
• Statistical tools and simulation software
• Molding processes and their validation (preferred)
• SPS Methods (preferred)
• Creation of specification for equipment and tools to be used in development
• You have experience in project teamwork across functional areas and departments
• You have experience in working directly with suppliers on technical matters
• Preferably knowledge of Design Control (ISO 13485 and 21 CFR part 820.30)
• Software: Microsoft Office tools, SolidWorks and AutoDesk Inventor, Simulation tools, tolerance chain. tools, statistical tools
• Fluency in English
  

What we offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.

We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun 😊

Some of the facts and a little piece of history
Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global medtech partners. New ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements.

Want to join our team?