Vivani Medical, Inc→
Head of Technical Development at Vivani Medical, Inc in Alameda, CA
Skills
Job Description
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.
You will oversee internal and external development partners, manage design control and technology transfer, and collaborate closely with Operations, Quality, Regulatory, and Clinical teams to ensure timely and successful program execution.
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.
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
Salary Range: $195,000 - $250,000
Final compensation will be determined on job-related factors such as experience, education, and training.
- 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