Saluda Medical seeks a Senior Mechanical Engineer to contribute to the development of advanced implantable Neurostimulation devices. This global role involves collaborating with diverse teams across various stages of product development, from research and development to manufacturing transfer.
Responsibilities:
Device Design and Optimization: Lead the design, development, and optimization of neuro-lead interfaces and implantable medical devices to meet project goals and timelines.
Cross-functional Collaboration: Collaborate closely with R&D, engineering, and clinical teams to ensure alignment of designs with project objectives, incorporating feedback from clinical trials and user studies.
Innovation and Integration: Drive innovation by incorporating advanced modeling techniques, staying informed about industry trends, and ensuring the seamless integration of electrical stimulation and modulation techniques into implantable devices.
Key Responsibilities:
- Design, prototype, and iterate on new implantable medical devices, incorporating feedback from clinical trials.
- Develop mechanical designs for next generation neurostimulators, considering complex electronics integration.
- Utilize 3D modeling and rapid prototyping techniques for early design iterations.
- Document designs thoroughly for verification and validation activities.
- Lead sub-projects and collaborate with external manufacturing teams for design transfer and production optimization.
- Compile and analyze operational data to establish technical specifications and ensure compliance with industry standards.
- Develop device history files including requirements, risk management, and usability files.
- Support regulatory filings and intellectual property development.
- Managing relationships with Contract Manufacturers providing guidance on process development
- Prior experience with labelling would be an advantage
Qualifications:
- Bachelor's degree in engineering (Mechanical Engineering, Manufacturing Engineering, or related field).
- Experience with FDA regulations (21 CFR 820.30) and international standards (IEC 60601-1).
- Experience in R&D activities related to electro-mechanical implantable medical devices.
- Self-starter with the ability to work independently and collaboratively in a multidisciplinary environment.
