Are you ready to play a crucial role in revolutionizing healthcare? My client is currently seeking a highly skilled Principal or Senior Design Assurance Engineer to join a dynamic team in Galway, (Hybrid). In this role, you will be instrumental in shaping the development of a cutting-edge patient-facing medical device, impacting the lives of those undergoing treatment.
Key Responsibilities:
- Lead Design Assurance activities, including risk management, test method validations, and design solutions.
- Collaborate closely with the Research & Development team to ensure adherence to ISO standards and regulatory requirements.
- Drive project goals by effectively managing external suppliers and manufacturing partners.
What's In It for You:
- Join a rapidly growing company in its early stages, contributing to the development of a high-impact medical device.
- Competitive salary and stock compensation on par with leading multinational medical device companies.
- Enjoy a flexible work environment with work-from-home options, emphasizing quality of life for both our product and our team members.
Experience Requirements:
- 5+ years of experience in R&D and/or Design Quality Assurance within the medical device industry.
- Degree in Engineering or Scientific field, or equivalent experience.
- Strong understanding of FDA guidance, ISO 13485, ISO 14971, and medical device regulatory requirements.
- Proficient in technical writing and communication.
- A creative problem solver with a passion for bringing innovative products to market.
- Proactive team player, eager to learn and contribute to team development.
- Resourceful, independent, and self-motivated, with a hands-on attitude.
- Exceptional written and verbal communication skills.
Experience Advantages (Desirable):
- Previous experience with Class II electromechanical medical devices.
- Lead auditor training.
- Experience with IEC 60601.