Production Lead

• 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

• A minimum of 8 years of direct manufacturing or related experience in the medical device industry; or equivalent combination of education and work experience.
• Must be certified on all processes including as an expert on all critical processes.
• Highly skilled in product manufacturing, testing, and data collection.
• Strong math skills, and proficient in Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and requirements.
• Ability to train others to processes and procedures and lead without formal authority.  Strong ability to work with and clearly communicate (in writing or verbally) with cross functional teams and Engineers.
• High skill operating manufacturing equipment (i.e. hot boxes, adhesives, soldering, bonding, fuse joining).
• Proficiency in Microsoft office products with strong interpersonal skills, effective interaction with Operations and other departments, including resolution of discrepancies/documentation errors.
• Detailed oriented and demonstrated high level of inventory control skills.
• Experience with accurately verifying others’ work for accuracy (i.e. work content, actual part counts, LHR documentation).
• Prior experience in Catheter assembly processing (including sub-assembly processes) is preferred.

Last updated on Oct 10, 2024