Nanobiosym is an innovative, high-tech company that is developing novel technologies at the nexus of physics, nanotechnology, and biomedicine. Founded by MIT/Harvard alum and located in Cambridge, Massachusetts, Nanobiosym was awarded the first X-Prize to be given for healthcare.
Summary
* Coordinate a variety of advanced engineering and innovative manufacturing processes.
* Collaborate with team members and management to develop and improve processes and build regulatory documentation.
* Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that complies with ISO 13485 regulations.
* Provide troubleshooting focus and direction for the team with details of root cause analysis.
* Utilizes DRM/COS/Lean principles to develop creative, thorough, and practical technical solutions.
* This is a hands-on position in a growing organization and an opportunity that will grow rapidly
QUALIFICATIONS
* MS. or B.S. or Ph.D. in Engineering (Plastics or Mechanical preferred)
* Six Sigma Black Belt, a plus
* Preferred 5-7+ years of experience in molding, mold-making and tooling in a manufacturing environment
* 5-7+ years of experience in diverse technical, materials, manufacturing, and product design
* Preferred- Experience in statistical analysis and statistical process control
* Preferred- Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment
* Good communication, documentation and organization skills
Job Types: Full-time, Part-time, Contract, Temporary
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Paid time off
- Referral program
- Relocation assistance
- Retirement plan
Schedule:
- 10 hour shift
- 8 hour shift
Work Location: In person