Senior Engineer, Mechanical Engineering- CA

Synchron Inc. • San Diego, CA

7h • $140,000 - $160,000 • Onsite

About The Position

We are seeking a R&D Mechanical Engineer to own the mechanical design and development of Synchron’s Implantable Receiver and Transmitter Unit (IRTU). This individual will lead the design of a hermetically sealed electronics packaging that must function reliably inside the human body for years, interfacing closely with electrical, firmware, and systems engineering teams to deliver an integrated implantable platform.

 This is a deeply technical, hands-on role. The successful candidate will drive mechanical architecture decisions from concept through verification, balancing biocompatibility, manufacturability, thermal management, and regulatory requirements as the program scales toward pivotal trials.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related discipline
• 5+ years of experience in mechanical design of miniaturized, high-reliability electromechanical systems
• Demonstrated expertise in hermetic packaging, precision assembly, and biocompatible materials
• Proficiency with 3D CAD (SolidWorks or equivalent)
• Strong understanding of GD&T, tolerance stack-up analysis, and mechanical drawing standards
• Hands-on experience taking mechanical subsystems from prototype through design verification and into production

Nice To Haves

• Active implantable medical device experience (e.g., neurostimulators, cochlear implants, cardiac rhythm devices)
• Experience with hermetic sealing technologies such as laser welding, brazing, or diffusion bonding
• Background in thermal management of implantable electronics
• Familiarity with ISO 14708, IEC 60601, and FDA guidance for implantable devices
• Experience supporting regulatory submissions (IDE, PMA, or 510(k)) with mechanical design evidence
• Track record of working in cross-functional hardware teams in a startup or high-growth environment

Responsibilities

• IMPLANT MECHANICAL DESIGN & ARCHITECTURE
• Own the end-to-end mechanical design of the IRTU implant, including hermetic enclosures, feedthroughs, internal component packaging, and structural interfaces
• Drive miniaturization strategies that meet volumetric constraints while preserving thermal, electrical, and structural performance
• Define and maintain mechanical interface control documents across the implant system
• Lead trade studies and design reviews for enclosure geometry, sealing methods, and material selection
• BIOCOMPATIBILITY & HERMETICITY
• Specify materials and surface treatments compatible with long-term implantation (titanium, ceramic, biocompatible polymers)
• Design and validate hermetic sealing approaches (laser welding, brazing, glass-to-metal seals) to ensure implant longevity
• Collaborate with biocompatibility and quality teams to ensure compliance with ISO 10993 and related standards
• Define accelerated aging and environmental test protocols for mechanical subsystems
• THERMAL & STRUCTURAL ANALYSIS
• Perform and oversee thermal modeling to ensure implant surface temperatures remain within safe biological limits
• Conduct finite element analysis (FEA) for structural integrity under implant loading conditions, including drop, vibration, and pressure
• Validate analytical models against bench and environmental test data
• MANUFACTURING & PROCESS DEVELOPMENT
• Develop manufacturing processes for implant assembly, including precision bonding, micro-assembly, and clean-room operations
• Own mechanical DFM/DFA and drive design iterations to support scalable production
• Partner with contract manufacturers and internal fabrication resources to establish robust, repeatable build processes
• REGULATORY & DESIGN CONTROLS
• Serve as mechanical engineering lead within the design controls framework (e.g. ISO 14708)
• Author and maintain mechanical design inputs, risk analyses, and verification/validation protocols
• Support regulatory submissions with mechanical test reports, design rationale, and traceability documentation
• CROSS-FUNCTIONAL COLLABORATION
• Partner closely with electrical, firmware, and systems engineers to co-optimize the implant across all domains
• Work with the Stentrode Kit team and delivery system engineers to ensure mechanical compatibility at the system level
• Contribute to failure analysis and root-cause investigations spanning mechanical, electrical, and environmental factors

Benefits

• Subsidized medical and dental insurance coverage for you and your dependent(s)
• Life insurance, short-term disability, long-term disability
• 401k
• Discretionary unlimited PTO
• Flexible Spending Account for you and your dependent(s), with eligible plan elections
• Commuter benefits for NY employees

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees