Job Details

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
To be successful in this role, you'll 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. You'll also follow design control processes to develop specifications, design verification and validation plans, design transfer plans, and associated completion reports. You will identify critical process parameters and develop control plans to mitigate risks. This role reports to the COO.

III. Education and Experience

1. Masters Degree in Life Sciences, Material Science, Engineering, or related field. PhD preferred.
2. 10+ years of experience in the Medical Device/biotech industry, with at least four years at a precommercial company.
3. Hands-on experience managing technology, including technology selection, development partner selection, design development, and product life-cycle management.
4. Demonstrated product development experience across various stages of development.
5. Good understanding and work experience in device development, combination drug/device products concerning cGMP, FDA, and Global regulatory requirements.
6. Technical expertise in design and development of class 3, implant medical device, and/or medical device/drug combination products.
7. Demonstrated leadership and extensive knowledge of compliance to ensure adherence to engineering best practices and industry standards.
8. Strong management and critical thinking skills to manage and adhere to the demands of on-time completion within budget constraints.
9. Strong organizational skills with the ability to effectively manage multiple priorities and communicate written and verbal results.
10. Work with colleagues in the office three days a week.