Sr. Manufacturing Engineer

This is a rare opportunity. If you have wondered what it would be like to take everything that is good and efficient from the systems you have worked in and apply it at the ground floor of a fast growing company, now is your chance. We are looking for the right person to expand and improve Novidan’s manufacturing. If a high amount of visibility, responsibility and ownership interests you, please read more and apply.

Summary

The Manufacturing Engineer is responsible for the efficient operation of the manufacturing of Class I and Class II medical devices. This includes medical device manufacturing, testing, labeling, and packaging. This role effectively monitors and consistently improves: flow of material in and out of the facility, incoming inspection, production line efficiency, and reporting of key production metrics. This position reports directly to the COO.

Job Responsibilities

  • Owns the implementation and reporting on production data metrics using Statistical Process Control (eg. First pass yields, takt time, on-time delivery)
  • Owns Incoming Inspection measurements and reporting
  • Implements lean manufacturing initiatives including demand-driven continuous flow, 5-S, and elimination of waste through value stream analysis.
  • Owns preventive maintenance of production equipment and fixtures
  • Introduce and validate new equipment to medical device manufacturing lines using IQ/OQ/PQ.
  • Create documentation in alignment with FDA regulations and ISO 13485 guidelines, including Master Validation Plans, pFMEA’s, and Work Instructions.
  • Effectively applies Six Sigma principles such as DMAIC, visual factory, kanban, and kaizen
  • Lead cost reduction projects for production lines.
  • Create, review and approve ECR’s
  • Collaborate closely with R&D in new product introduction
  • Troubleshoot complex systems and drive to root cause, independently and as a team
  • Communicates clearly with company leadership and key customers on topics related to production
  • Perform other duties commensurate with an engineering role at Novidan.

Job Requirements

Education

B.S. in Manufacturing Engineering, Mechanical Engineering or equivalent degree required.

Six Sigma Black Belt preferred

Experience

5+ years engineering experience in a production environment required. Medical device manufacturing experience a significant plus.

Sr. Manufacturing Engineer II: 10+ years engineering experience in medical device manufacturing operating under FDA QSR and ISO 13485 requirements

Job Knowledge and Skills

  • Advanced proficiency in troubleshooting complex systems and driving to root cause required
  • Advanced proficiency in implementing Six Sigma principles required
  • Advanced proficiency in Microsoft Office required.
  • Intermediate proficiency with statistical software tools (eg. Minitab) required
  • Intermediate understanding of FDA 21CFR820 desired
  • Familiarity with ISO 13485 guidelines desired
  • Knowledge of injection molding processing and tooling desired
  • Intermediate knowledge of geometric dimensioning and tolerancing desired
  • Interest in acoustics desired

Working Environment

Medical device manufacturing and normal office conditions. Must be able to lift up to 50 lbs.

Travel

Less than 10%. Some US or international travel may be required.