MitraClip Specialist Lead I

The Opportunity

This position works out of our Westfield, IN, location in the Structural Heart division.

Main Purpose of Role: Coordinates daily work for production personnel, moving operators around as necessary to maximize output and reduce WIP levels. Assist the supervisor in developing action plans to hit required output. Performs production reviews to ensure high level of quality before releasing product. As necessary, assembles MitraClip device subassemblies and finished goods in accordance with approved manufacturing procedures. Performs a wide variety of assembly operations including heavy microscopy use, soldering, complex gluing operations, fusing of materials, precise loading/alignment of components, and numerous inspections in accordance with complex manufacturing process instructions.

What You'll Work On

• Understands Line Balance, performs hourly line walks and adjusts headcount to achieve daily targets
• Accurately summarizes activities/downtime/rejects on Production Summary and Line Sheet
• Performs eLHR production reviews as lot comes off line, with ability to catch and raise quality concerns
• Identify potential Quality System gaps, communicate to Engineering, and remediate as appropriate
• Run daily Tier I meetings with operators to focus on goals, quality, safety, and productivity, and yield
• Coordinate trainings with oversight from supervisor on which stations/operators need to be trained.
• Able to train to and achieve standard work and assembly time on 7-8 stations.
• Utilize 5S tools to improve station layout
• Provides feedback on larger procedural updates to address compliance gaps or areas for performance improvement.
• Ability to train other operators to procedures, and explain key aspects of JBS
• Understands role in PFM and can direct him/herself and others when the supervisor or lead is unavailable. Proactively rotates to lower WIP levels as needed.
• Prioritizes daily tasks with minimal oversight, provides materials requests proactively in advance
• KOL in given area and provides feedback on how to improve work flow from quality, safety and production standpoint. Can identify potential quality issues and work with Engineering to help resolve issues/inconsistencies.
• Go-to person for when auditors are on the line
• Ability to train to and build any of the 8 product types (NT, NTR, XTR, NTW, XTW, G4-NT, G4-XT, TriClip)
• Perform changeover from one product type to another, on station using changeover matrix, and escalate to lead, supervisor, or equipment group depending on what product the station is changing from and to. Requires comprehensive knowledge of various tools/equipment/fixtures for various product types.
• On the clip line, complex dexterity under microscope, using hot knife to smooth Clip cover material to very precise specifications, and razor blades to make straight cuts on rounded edges. Differences in requirements for each of the 8 different Clip product types.
• On the clip line, under microscope, tying suture knots to very precise square knot
• On the CDSF line, requires high levels of focus and cognition on DC to handle bonding to complete complex processing steps to use surface primers, multiple types of glue, articulating fixtures, multiple alignment gages, multiple UV curing cycles, and multiple bonds all within a single station/fixture/procedure.
• Clip loading involves a 51-page procedure, with multiple actions to load the Clip onto a catheter, with different steps/judgements/decisions based on any of the 8 product types that may be built at that station. Gen 4 specifically requires loading and trapping a .004" thick wire with a .017" ball on the end within a .020" hole, while managing components at both the distal and proximal end of the five-foot-long device.
• On the SGCF, SGCS, and Sleeve Lines, melting and forming of catheter shafts while using judgement to determine when proper melting and flow of materials has been achieved.
• Precise manual Skiving operations, for which a cut that is not deep enough will result in inability to retrieve cables, and a cut that is too deep will cause failed leak tests.
• Ability to read, comprehend and implement lengthy, complex procedures written in English
• Maintain clean room integrity by using proper attire and adherence to clean room environment practices and procedures
• Records information on approved documents, and follows good documentation practices

Schedule

Monday - Friday, 6:00 am - 2:30 pm, with potential overtime

Required Qualifications

• High School Diploma / GED
• Minimum 6 years related work experience (2 years must be as Lead)

Preferred Qualifications

Preferred quals here