Head of Technical Development

About the Role

The Head of Technology Development is a senior technical leader responsible for defining and executing the end-to-end technology strategy for Vivani’s device and drug-device combination product portfolio. This role drives innovation, leads cross-functional development programs, and ensures that products meet the highest standards of safety, performance, and regulatory compliance from concept through commercial launch.

Key Responsibilities

• Technology & Product Development Leadership

• Provide strategic leadership for all technology development activities across multiple device and combination product programs.

• Own the technology roadmap and ensure alignment with company goals, clinical needs, and commercial scalability.

• Lead product development from concept feasibility through design, verification, validation, clinical support, and commercialization.

• Serve as the technical authority and decision-maker for device architecture, materials, processes, and risk mitigation.

• Design Control & Regulatory Compliance

• Ensure full adherence to design control processes, including requirements development, specifications, verification/validation planning, and design transfer.

• Oversee creation and approval of documentation such as design history files, technical reports, validation summaries, and risk management files.

• Partner with Regulatory Affairs to support submissions and ensure compliance with FDA, cGMP, ISO, and global regulatory expectations.

• Cross-Functional Collaboration

• Collaborate closely with Operations to identify and deploy technologies that improve manufacturability, reduce cost, and enhance yield and process capability.

• Work with Clinical and Quality teams to ensure product readiness for clinical trials and post-market requirements.

• Communicate program status, risks, and mitigations clearly to executives and stakeholders.

• External Partner, Vendor & CMO Management

• Lead the selection, onboarding, and management of technology partners, development firms, and contract manufacturing organizations (CMOs).

• Ensure external teams deliver high-quality work that aligns with program milestones, budgets, and compliance expectations.

• Establish and maintain strong technical oversight, review processes, and performance metrics.

• Risk Management & Continuous Improvement

• Identify critical process parameters and create robust control strategies to ensure safety, performance, and manufacturability.

• Promote best practices in engineering, quality, and program management across the organization.

• Drive continuous improvement initiatives to strengthen design robustness, reduce variability, and accelerate development timelines.

Requirements

• Ph.D. (or equivalent) in Engineering, Life Sciences, Materials Science, or a related field.

• 15+ years of experience in the medical device or biotech industry, including at least 5 years in a pre-commercial or early-stage company.

• Demonstrated leadership in developing Class III implantable devices and/or drug-device combination products.

• Deep understanding of cGMP, FDA regulations, ISO standards, and global regulatory frameworks.

• Proven experience managing design control, product development processes, and technology transfer.

• Strong track record of leading cross-functional teams and managing complex, multi-stakeholder programs.

• Exceptional communication, organizational, and problem-solving skills.

• Experience overseeing CMOs and external development partners.

• Experience advanced materials, drug delivery systems, and implantable devices.

• Experience scaling products from prototype to commercial manufacturing

Pay

Salary Range: $195,000 - $250,000

Final compensation will be determined on job-related factors such as experience, education, and training.

Benefits

• Medical
• Dental and Vision
• Flexible Spending Account (FSA)
• 401K with Company Safe Harbor Match: 100% /up to 4%
• Life Insurance
• Long Term Disability
• Home Office Stipend
• Commuter benefits