Bluejay Diagnostics is a rapidly growing medical device company focusing on rapid near-patient diagnostics. We strive to innovate in ways which completely change the medical decision-making process, ushering in a new era of healthcare. To help us with our mission, we are searching for a Senior Process Engineer to work on our revolutionary Symphony product lines. This person will work with a multidisciplinary team to design, optimize, and scale manufacturing.
- Support the manufacturing operations team.
- 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.
- Bachelor’s degree or higher in engineering or related scientific disciplines.
- Minimum of 3 years of experience as a process engineer
- Experience in cGMP manufacturing
- Experience in medical device 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).
- Travel, including international travel up to 20%
- Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject review between employee and manager throughout tenure.
- Paid time off
- Health insurance
- Dental Insurance
- Vision insurance
- Parental leave