We are partnering with an innovative and fast-growing medical technology company that is developing groundbreaking solutions to improve the quality of life for patients. Their latest product, a cutting-edge medical device, is in development, and they are seeking a Senior R&D Engineer to lead its journey from concept to market-ready product.
Key Responsibilities:
- Lead the development of medical devices, contributing to technical reviews, prototyping, and the manufacturing process.
- Develop and refine prototypes using techniques like injection moulding, vacuum casting, and 3D printing, ensuring manufacturability and design optimization.
- Evaluate materials and suppliers, ensuring practical, high-quality designs.
- Collaborate with cross-functional teams, including design assurance, manufacturing engineers, and project management, to ensure alignment and success.
- Conduct risk assessments and work on testing to validate product safety and effectiveness.
- Mentor junior team members, providing technical leadership and guidance.
Key Requirements:
- 6+ years of R&D experience, with 4+ years in the medical device sector.
- Expertise in product development, including documentation (Design History File) and design for assembly/manufacturing.
- Hands-on experience with prototyping techniques (e.g., injection moulding, 3D printing).
- Strong understanding of medical device regulatory standards, including FDA, MDR, ISO 13485, and IEC 60601.
- Methodical, organized approach with excellent problem-solving skills.
Preferred Skills:
Experience with wearable products or textiles.
CREO CAD proficiency and familiarity with sterilisation and electromechanical devices.