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The Mullings Group · 3 days ago

Principal Mechanical Engineer : 1st Gen Neuromodulation Concept

Fremont, CA

Full-time

Onsite

Lead/Staff

10+ years exp

The Mullings Group is seeking a highly experienced Principal Mechanical Engineer to lead mechanical design efforts for a next-generation active implantable neuromodulation system. This role focuses on the development and optimization of implant mechanical design, requiring hands-on design, prototyping, testing, and iteration to bring products from concept through commercialization.

Health CareMedicalMedical Device

Growth Opportunities

Hiring Manager

Wesley Kennedy-Sita

Responsibilities

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

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

Generate and maintain design documentation in accordance with ISO 13485 and FDA 21 CFR Part 820 design control requirements

Contribute to risk management activities (ISO 14971), including FMEA and fault tree analysis

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

Qualification

Mechanical designActive implantable devicesCAD proficiencyBiocompatible materialsDesign for manufacturabilityRegulatory standards knowledgeCommunication skillsCross-functional collaboration

Required

Bachelor's degree in mechanical or biomedical engineering

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., SolidWorks, 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