OUR COMPANY

NextBeam is a startup company founded with the vision of improving how contract irradiation & sterilization get done. Our mission: be the most innovative and customer-centric irradiation provider in the world. We value teammates that are accountable, detail- and customer-oriented problem solvers. Together, we operate with a startup mentality and culture to deliver a high level of quality and reliability, work collaboratively, and take the initiative to identify and solve problems across our business.

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree in Operations Management, Engineering, Information Technology/Systems, or a related field
• 3-6 years of experience in Industrial Engineering or a related field
• Willingness / excitement at the prospect of having a strongly hands-on role
• Very strong skills with Google Suite and Microsoft Office applications (Word, Excel)

PREFERRED QUALIFICATIONS:

• Industry training for quality control, document control, or auditing (ASQ, AAMI)
• Experience working in a highly regulated environment such as medical device, pharmaceutical, aerospace, semiconductor or similar
• Working knowledge of good documentation practices (GDP), good manufacturing practices (GMP), quality systems (ISO 9001 or ISO 13485)
• Experience working in a laboratory environment and using lab equipment
• Experience with performing and maintaining calibrations or other verification / validation processes
• Certifications for project management skills (PMI, LEAN, Six Sigma)

ROLE SUMMARY

We are currently seeking a professional, hard-working, and reliable full-time Validation & Industrial Engineer (V&IE) to join our team. The V&IE has two key responsibility areas:

• Validation - be a hands-on engineer assuring that our critical-to-quality equipment and systems are functioning correctly to support operations within a highly regulated environment.
• Optimization - support the team by improving data collection systems and software integration efforts.

ESSENTIAL DUTIES:

Validation

• Assure key systems are functioning and validated properly: especially our electron beam irradiation system (which is supported by the manufacturer as a subject-matter expert.)
• Define validation protocols for a variety of systems (ovens, irradiation systems, dosimetry, etc.)
• Execute validation testing, interpret the results, and draft and execute followup changes, maintenance, or other next steps accordingly.
• Document the results of all of the above in accordance with our procedures
• Schedule, prioritize, and communicate status of validation testing according to a variety of factors including internal, customer, and compliance requirements

Optimization

• Manage the integration of data sources to improve our processes: we run NetSuite, house SQL data in Google Cloud, in addition to a variety of vendor systems. In-depth software engineering is not required, but a strong grasp of how these systems store and expose data for integration purposes is critical.
• Apply Six Sigma, Kaizen, Lean, value analysis, and value engineering tools to implement continuous improvement practices
• Perform analysis of process to project cycle times
• Implement industrial engineering and lean manufacturing practices to deliver the project savings, quality, safety, and productivity improvements required by leadership