Principal Mechanical Engineer : 1st Gen Neuromodulation Concept

Principal Mechanical Engineer : 1st Gen Neuromodulation Concept

Our client is seeking a highly experienced and technically proficient Principal Mechanical Engineer to lead mechanical design efforts for its next-generation active implantable neuromodulation system.

This role is critical to the development and optimization of the implant mechanical design including the lead systems, their mechanical architecture, biocompatibility, fatigue performance, integration with implantable electronics, and test method design and implementation. This position is development-focused, emphasizing hands‑on design, prototyping, testing, and iteration to bring products from concept through commercialization.

The ideal candidate will bring deep expertise in mechanical design active implantable devices and the associated leads including but not limited to neuromodulation, neurostimulation, cardiac rhythm management, pacemakers, and defibrillators and will play a key role in advancing this platform.

Responsibilities

Mechanical Design & Development

• Lead the design and development of implant mechanical design including lead systems, including conductor configurations, materials, fixation mechanisms, and strain relief.

• Develop mechanical components and assemblies that meet stringent requirements for biocompatibility, fatigue resistance, and long‑term reliability.

• Perform detailed mechanical analysis including FEA, tolerance stack‑up, and material selection for implantable applications.

System Integration

• Collaborate closely with electrical, firmware, and systems engineering teams to ensure seamless integration of the mechanical design with the electrical design and external components.

• Support the development of interfaces, feedthroughs, and packaging strategies.

• Define and execute mechanical verification protocols including tensile, flexural, fatigue, and environmental testing.

• Support preclinical and clinical evaluations with mechanical insights and design iteration.

Documentation & Compliance

• Generate and maintain design documentation in accordance with ISOand FDA 21 CFR Part 820 design control requirements.

• Contribute to risk management activities (ISO, including FMEA and fault tree analysis.

Innovation & Technical Leadership

• Serve as the subject matter expert on mechanical engineering and lead systems for implantable systems.

• Identify and evaluate new materials, manufacturing processes, and design approaches to improve device performance, reliability and manufacturability.

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering, Master’s degree in Mechanical Engineering or Biomedical Engineering preferred.

• 10+ years of experience in mechanical design for active implantable medical devices.

• Demonstrated expertise in active implantable mechanical device design, including: lead design, materials identification and selection, iterative prototyping, mechanical and environmental stress mitigation, and integration with electrical design.

• Proficiency in CAD (e.g., Solid Works, Creo), FEA tools, and mechanical simulation.

• Deep understanding of biocompatible materials, sterilization methods, and implantable device packaging.

• Experience with design for manufacturability (DFM) and working with contract manufacturers.

• Strong knowledge of regulatory standards and design controls for Class III medical devices.

• Excellent communication and cross‑functional collaboration skills.

• Must have partnered with Electrical Engineering in past development programs.

Additional Information

• Seniority Level: Director

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Employment Type:

Full‑time

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Job Functions:

Medical Equipment Manufacturing and Biotechnology Research

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