Senior Mechanical Engineer

Responsibilities

• Lead the design, development, and optimization of neuro-lead interfaces and implantable medical devices to meet project goals and timelines.
• 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.
• 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.
• Manage relationships with Contract Manufacturers providing guidance on process development.

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.