Head of Technology Development (Alameda, CA)

Cedent; Alameda (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

A leading biotech company in Alameda, CA seeks a Head of Technology Development to lead the design and commercialization of medical devices. This role requires extensive experience in product development, regulatory compliance, and hands-on technology management. The ideal candidate possesses a Master's degree or PhD and has over 10 years of experience in the medical device industry. Responsibilities include technical leadership across programs and adherence to engineering best practices. Hybrid work is expected with three days in the office.

Qualifications

• 10+ years of experience in the Medical Device/biotech industry.
• Hands-on experience managing technology selection and development.
• Demonstrated product development experience across various stages.

Responsibilities

• Act as the technical lead for multiple programs.
• Follow design control processes to develop specifications.
• Identify critical process parameters and mitigate risks.

Skills

Leadership

Critical thinking

Project management

Technical expertise in medical devices

Regulatory compliance knowledge

Organizational skills

Education

Masters Degree in Life Sciences, Material Science, Engineering

PhD preferred

Job description

Head of Technology Development (Alameda, CA)

In this role, you’ll lead the development of our device — a miniature, long-term drug implant with the client proprietary platform technology — from initiation through technology selection, development, clinical trials, and commercial launch, ensuring compliance with all regulatory requirements. As the Head of Technology Development, you’ll work flexibly across multiple programs with responsibilities including but not limited to managing development strategies across various stages of development, overseeing technology development activities at development partners and CMOs, and ensuring Client technology platform products are best in class. You’ll also develop strategies and oversee the execution of activities associated with product development and technology transfer.

II. Duties and Responsibilities

• Act as the device/drug product technical lead for multiple programs and assist operations with selecting and implementing appropriate technologies that result in lower manufacturing costs, lower process variability, and higher manufacturing capability.
• Follow design control processes to develop specifications, design verification and validation plans, design transfer plans, and associated completion reports.
• Identify critical process parameters and develop control plans to mitigate risks.
• Report to the COO.

III. Education and Experience

• Masters Degree in Life Sciences, Material Science, Engineering, or related field. PhD preferred.
• 10+ years of experience in the Medical Device /biotech industry, with at least four years at a precommercial company.
• Hands‑on experience managing technology, including technology selection, development partner selection, design development, and product life‑cycle management.
• Demonstrated product development experience across various stages of development.
• Good understanding and work experience in device development, combination drug/device products concerning cGMP, FDA, and Global regulatory requirements.
• Technical expertise in design and development of class 3, implant medical device, and/or medical device/drug combination products.
• Demonstrated leadership and extensive knowledge of compliance to ensure adherence to engineering best practices and industry standards.
• Strong management and critical thinking skills to manage and adhere to the demands of on‑time completion within budget constraints.
• Strong organizational skills with the ability to effectively manage multiple priorities and communicate written and verbal results.
• Work with colleagues in the office three days a week.