Bluejay Diagnostics is a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression. To help us with our mission, we are searching for a Principal Engineer to work on our revolutionary Symphony product lines. This person will work with a multidisciplinary team to design, optimize, and scale manufacturing.
- Lead process development from R&D to manufacturing.
- Design and optimize new manufacturing production lines.
- Drive continuous improvements and operational excellence through self-detecting processes and systems.
- Executes process changes stemming from process changes/optimizations, CAPAs, and new capacity demands.
- Perform other ad hoc assignments
- Bachelor’s degree or higher in mechanical engineering.
- +10 years of experience with medical devices
- Experience with cartridge-based systems preferred.
- Experience in cGMP manufacturing
- Experience in clean room environments
- Demonstrate strong organizational, time management, and problem-solving skills.
- Lead groups and work independently, without instruction.
- Understanding applicable regulatory requirements including FDA QSR and ISO 13485.
- Ability to function in a dynamic environment and balance multiple priorities simultaneously.
- PMP or similar certification (Preferred).
- Ability to commute/relocate to our Acton, MA office (Preferred).
- Ability to travel, including international travel
- Medical, Dental and Vision insurance
- Paid time off
- Parental leave
- 401(k) plan with company match
- Flexible spending account
- Stock Options
Industry: Medical Device and In Vitro Diagnostics
Job Type: Full Time