Job Description

Base Pay Range

$230,000.00/yr - $260,000.00/yr

Additional Compensation Types

Stock options

Company Info

10Person earlystage ActiveImplantable Medical Device startup company. Recently closed SeriesB Funding. Device: Groundbreaking wireless implantable device and remote monitoring system designed to enable personalized heart failure management and significantly reduce hospitalizations for patients with chronic heart failure.

Position Overview

Seeking a talented and motivated Director of Research and Development to join our team at our BayArea facility. This position offers handson experience with cuttingedge medical device technology. As Director of Research and Development, you will lead the development and optimization of the implantable sensor from prototype through clinical readiness for firstinhuman use. Youll take technical ownership of the devices most critical subsystem while collaborating with our multidisciplinary engineering team to deliver a safe, reliable, and manufacturable active implantable medical device. The ideal candidate thrives in dynamic startup environments, brings strong organizational and technical skills combined with a collaborative mindset, and is excited by the opportunity to make meaningful contributions to a product that will directly impact patient lives. This position offers the chance to shape the future of our technology and organization for the right individual.

Roles and Responsibilities

• Drive sensor from advanced prototype through design verification and OUS regulatory submission to firstinhuman clinical trial readiness
• Own verification and validation activities, ensuring compliance with applicable regulatory standards and internal quality requirements
• Manage supplier relationships for critical mechanical and electrical components
• Lead technical troubleshooting and implement innovative solutions to enhance device performance, reliability, and manufacturability
• Establish and maintain rigorous design documentation and traceability within the companys Quality Management System
• Contribute to crossfunctional design reviews and risk assessments to drive product maturation toward clinical milestones

Required Qualifications

• B.S. in Electrical Engineering, Mechanical Engineering, or related technical field
• 10+ years in medical device development with demonstrated experience working under FDA QSR, ISO13485, or equivalent quality systems
• Experience with ultrasound systems, acoustic sensors, or related technologies
• Experience managing suppliers of precision electromechanical components with documented quality agreements and performance metrics
• Handson prototyping capabilities spanning electronics, mechanics, and system integration
• Working knowledge of design controls, risk management (ISO14971), and regulatory pathways for medical devices
• Selfdirected problem solver with ability to balance independent technical work and collaborative crossfunctional initiatives
• Clear technical communicator with strong documentation practices
• Prior role in an earlystage medical device company or startup environment
• Proven track record developing and integrating electronic assemblies for medical devices

Preferred Qualifications

• Knowledge of ISO14708 requirements and tests for active implantable devices
• Background in digital signal processing or related analytical techniques
• Experience with PCB design, SMT assembly, and related CAD software
• Familiarity with wireless powering and data communication systems

What We Offer

• Meaningful Impact on lifesaving cardiac technology
• Growth Opportunity with increasing responsibility as we scale
• Collaborative Culture with experienced medical device professionals
• Competitive Compensation including equity participation and PTO
• Comprehensive Benefits including health, dental, and vision coverage

Contact: Jim Smith

Seniority Level: Director

Employment Type: Fulltime

Job Function: Medical Equipment Manufacturing

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