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BALT Group

Neuroradiology and vascular surgery medical tech

Operations Excellence Manager

Manufacturing & Process EngineeringPosted on Nov 12
Full-timeIrvine, CA, USA$130k - $150k

About the Job

Requirements

  • A bachelor's degree in Industrial, Mechanical or Manufacturing Engineering, Operations Management, or a related field, or equivalent experience.
  • At least 7 years in manufacturing operations or continuous improvement, including at least 3 years leading improvement programs or people.
  • Lean Six Sigma Green Belt or higher.
  • A proven record of leading kaizen events and delivering measurable gains in quality, throughput, lead time or cost.
  • Strong data skills, including Excel, Minitab or similar tools, and building KPI dashboards.
  • Ability to communicate clearly, coach operators, influence supervisors and present to senior leaders.
  • Comfort spending most of the day on the production floor.
  • Ability to stand and walk for long periods and wear PPE or cleanroom gowning as required.

Responsibilities

  • Build and own the site's operational excellence roadmap, aligned with business goals for safety, quality, delivery, cost and people.
  • Prioritize improvement projects by impact and effort, and maintain a visible portfolio of active work.
  • Set up and maintain the KPI framework, including OEE, first-pass yield, scrap, on-time delivery, lead time and WIP, and tiered daily huddles.
  • Lead kaizen events, value stream mapping, 5S, standard work, line balancing and visual management.
  • Improve production planning and flow so lines build the right quantity at the right time, reducing subassembly shortages and expediting.
  • Drive pull systems, Kanban and setup reduction where they fit the product mix.
  • Lead structured root cause analysis using A3, 8D, 5 Whys and fishbone methods for recurring production, receiving and quality issues.
  • Partner with Quality to support CAPA, nonconformance reduction and process validation.
  • Ensure every change follows document control and change management under ISO 13485 and FDA 21 CFR Part 820.
  • Coach supervisors and leads to run improvement on their own lines rather than depending on the CI team.
  • Train employees in Lean and problem-solving tools, and run Yellow Belt and Green Belt programs.
  • Set up and run an employee idea system with clear response times and recognition.
  • Manage and develop CI specialists assigned to the team.
  • Track and report validated savings and KPI gains to operations leadership monthly.
  • Sustain gains through audits, layered process checks and control plans.
  • Support capital projects, line layouts and workstation design with a Lean lens.

Desired Qualifications

  • Lean Six Sigma Black Belt.
  • Experience in medical device or another FDA-regulated industry, working under ISO 13485 and 21 CFR Part 820.
  • Experience with ERP/MRP systems such as SAP or Oracle, and production planning.
  • Background in high-mix, low-volume or cleanroom assembly.
  • Experience building a continuous improvement culture from the ground up or through a Lean transformation.

About the Company

BALT Group

Neuroradiology and vascular surgery medical tech

BALT GERMANY GmbH specializes in medical technology for clinical neuroradiology, radiology, and vascular surgery. It develops and supplies devices and solutions used in these fields and emphasizes expert consultation and qualified clinical care for complex therapies. The company differentiates itself through its comprehensive support—combining technical products with specialized medical guidance and hands-on therapy management—rooted in its Düsseldorf base (and history as ab medica). Its goal is to provide reliable, clinically effective neuroradiology and radiology solutions and patient care by pairing product delivery with dedicated professional consultation and therapy integration.

Company size
11-50
Company stage
Debt Financing
Total funding
$390.5M
Headquarters
Düsseldorf, Germany
Founded
2006

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