Our client, an innovative blue-chip medical device manufacturer based in Ireland, are expanding their product portfolio to include a range of new products focused on delivery of minimally invasive medical devices for the treatment of valvular heart disease.
Given this expansion, we are now actively recruiting for a Principal R&D Engineer who will be responsible for the design and develop of this next generation products.
The successful candidate will work within a dynamic New Product Development Team specialized in transcatheter heart valve system development for commercialization in all major global healthcare markets.
This is a permanent role, based in Galway.
Responsibilities of Principal R&D Engineer, Leadership role:
- Lead engineering design, development and support of next generation and current generation transcatheter heart valve products.
- Apply Mechanical and Biomedical Engineering knowledge to the design, development and assessment of prosthetic heart valves.
- Create/develop technical capabilities and expertise related to the design and testing of heart valve technology.
- Develop hydrodynamic and fatigue test methods and characterisation techniques to evaluate performance of valve prototypes.
- Perform necessary tasks to successfully translate designs from proof of concept through commercialization.
- In conjunction with product planning / marketing, collaborate with leading physicians and experts for the purpose of identifying and clarifying customer needs, plans, goals, and progress.
- Conduct tests utilizing existing test protocols, or develop new ones as needed and generate related written reports
- Participate in the specification and direct completion of specific verification/validation testing and analyses required that satisfy both regulatory and internal requirements.
- Document concepts, designs and design modifications in accordance with internal policies, industry standards and FDA requirements.
- Coordinate with outside consultants and clinicians to ensure testing and analyses required to fully qualify and verify device designs are appropriately representative of expected use conditions.
- Provide clear and regular technical direction to personnel assigned to a project
- Prepare or direct the preparation of oral and written reports of current status, progress and status of total project, as required by the customer, project or department Management.
Requirements for Principal R&D Engineer, Leadership role:
- Bachelor's degree in Mechanical Engineering or Biomedical Engineering is required. An advanced degree, i.e. Masters and / or PhD is a distinct advantage.
- 9+ years’ experience with BS Degree / 7+ years’ experience with MS Degree / 4+ years’ experience with PhD.
- This position requires relevant mechanical/biomedical engineering experience to include heart valve development, exposure to design of experiments, specification development, and prototyping.
- Prior experience in an interventional, vascular or cardiac surgery arena is a plus, especially involving prosthetic tissues and catheter based technologies.
- Proven Project Management and strong communication & presentation skills.
Please contact Larry on +353 1 2302400 / firstname.lastname@example.org / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.