Production Lead

1 day ago

Campbell, California, United States Imperative Care Full time
Job Title: Production Lead

About the Role
This is a highly specialized position responsible for building various company products while ensuring compliance with all quality systems and processes. The ideal candidate will have a minimum of 8 years of direct manufacturing or related experience in the medical device industry, with a strong background in product manufacturing, testing, and data collection. They will be certified on all processes and have a high level of skills to assist and mentor others in production processes, lead times, and quality standards.

Key Responsibilities
  • Utilize strong verbal and written communication skills to interact with and provide guidance to the CER team members.
  • Encourage teams to meet production outputs, and metrics/objectives adhering to quality standards.
  • Advise assigned team with limited direction from the production supervisor.
  • Effectively fill in for a supervisor when not available.
  • Train others, oversee production floor activities as needed, perform lot history records (LHR) reviews and complex troubleshooting activities, and notify engineering/maintenance of escalated issues.
  • Ensure accuracy of records on LHR, and adherence to all GMP/GDP policies by assigned team.
  • Collect daily output data for management review and coordinate Engineering Build Request (EBR) and Rework activities including training, execution of EBR, and documentation review.
  • Consistently meet the average cycle time and quality standard requirements for stations/processes to which it is trained and certified.
  • Flex and rotate through production stations as necessary or assigned.
  • Analyze production metrics to suggest improvements for inefficiencies on the production floor and maximize production output while ensuring high product quality.
  • Work with Engineers to develop new processes, provide feedback for the creation of new documentation (i.e. MPI, SOP), and train others to these documents (as needed).
  • Identify improvement opportunities for tooling/fixtures.
  • Recommend and initiate actions to prevent the occurrence of product non-conformity while implementing and verifying solutions.
  • Process small parts under a microscope.
  • Understand and follow safety policies and practices, and escalate issues related to product quality or workplace safety in a timely manner.
  • Co-champion (with the Supervisor) the 6S principles and goals

What We Offer
As a valued member of our team, you will receive a competitive salary, stock options, a 401k plan, health benefits, generous PTO, and a parental leave program. Join us in our mission to revolutionize stroke care and make a real impact on patients.

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