About the Role:
A leading Medical Device manufacturer are looking for a Senior Design Engineer to join their team in Galway. If you have the ability to develop medical device products in compliance with applicable regulations including EU and FDA regulations, then you could be the Senior Engineer that we've been looking for.
Who will you be working for?
My client is ranked among the top 10 device outsourcing manufacturers in the world and are currently looking to expand their Design Services team due to internal promotions and investment. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Their connectivity and sensor solutions are essential in today's increasingly connected world. You will be working for a company who strive to make positive changes to the environment and communities across the world.
What will you be doing?
- As a Senior Design Engineer, you will join a team of 15 people and you will provide technical leadership and support to the R&D project team in relation to the development and commercialisation of platform delivery system products.
- You'll manage the development of products and processes, ensuring that they meet customer requirements through the design phase. Your leadership skills will be utilised when managing a team of engineers and technicians within the R&D group.
- You will be targeted to work on 3-4 projects at a time.
- Ensure the application of new and existing technologies to provide the optimum delivery system design.
- Compile project plans and lead team to develop devices in accordance with planned activities, budget and timelines.
- Lead Design Reviews and the compilation of associated documentation.
- Some travel of up to 4 week per year required to visit clients for brainstorming sessions.
What skills/experience should you have?
- An engineering, science or equivalent degree.
- 5 to 8 year's industry experience in a medical product development environment with a proven track record of leading teams in device development.
- Experience of coordinating and leading Design Reviews.
- Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities.
- Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
- Proven experience in leading teams performing FMEA's, verifications and validations for medical devices products and processes.
What can we offer you?
- Pension contribution
- Excellent salary
- An exciting career with a great opportunity for progression
If you are interested in applying for this position or would like to hear more forward your CV we can organise a call when you are free. Otherwise if you know of someone who might also be interested in this position, please feel free to forward them my details.
Looking forward to hearing from you.
Sthree UK is acting as an Employment Agency in relation to this vacancy.