Job Summary
An engineering and project management company is searching for a person to fill their position for a Telecommute Combination Products Principal Device Engineer.
Candidates will be responsible for the following:
- Reviewing and approving of technically complex documentation
- Authoring of response letters to regulatory bodies
- Serving as a Single Point-of-Contact (SPOC) on multiple projects as the technical lead representative
Position Requirements Include:
- Bachelor’s degree in Biomedical, Mechanical, or Chemical engineering, or other technical discipline or equivalent
- 7+ years of experience in development and manufacturing in the pharmaceutical, biotechnology, and combination product sectors
- Experience with pre-filled syringes, auto pen injectors, co-packaged kits, and/or other combination product platforms
- Demonstrated level of medical device and biologic and/or drug experience
- Ability to motivate self, team members, and direct reports
- Excellent problem-solving skills
