Principal R&D Engineer Role
This is a key leadership position that oversees the development of medical devices, ensuring they meet regulatory requirements and deliver exceptional performance.
Key Responsibilities:
* Lead device development across multiple portfolios, providing technical expertise and guidance to cross-functional teams.
* Develop and maintain device design specifications, performing thorough characterization throughout the design development program.
* Facilitate collaboration between drug product and device teams during combination product development, ensuring seamless integration and optimal results.
* Provide technical support to manufacturing sites, assisting in filling and assembly process development and ensuring compliance with regulatory standards.
* Oversee metrology, engineering verification, design verification, device functional stability, defect management, biological evaluation, extractables/leachable, specifications & method development, and transport & shipping studies.
* Analyze and interpret analytical and manufacturing data, including compilation of technical reports and presentation of findings to stakeholders.
* Conduct critical reviews of device analytical and manufacturing control strategies for projects, identifying areas for improvement and recommending solutions.
Requirements:
* A Master's or Doctoral degree in Engineering or Science with 7 years of experience in late-stage R&D or Technical Support environments.
* Previous experience working as an Engineer or Scientist role in regulated and GMP environments on injectable devices.
* A strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
This is a fast-paced environment requiring high innovation and organizational skills, excellent planning and communication, and the ability to work under pressure and solve complex problems effectively.