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Operations Excellence Manager

  • Irvine, CA, United States

$130,000 - $150,000 USD

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Job details

Pay
$130,000 - $150,000 USD
Posting language
English
Posted

Original job description

About Balt

Our purpose is to improve the lives of 150,000 patients in 2026.

Our story

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

Why Join Balt? Join a passionate team, dedicated to making a difference.

  • Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
  • We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
  • Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
  • No matter the country, we take care of you.

Would you like to be part of our story? Don't hesitate, come and join us!

About this opportunity – Operations Excellence Manager

Description:

The Operational Excellence Manager leads our continuous improvement program, using Lean and Six Sigma to make production safer, faster, higher quality and less costly. This role partners with production supervisors, engineering, quality and supply chain to find waste, solve root causes and build improvements that stick on the floor.

The ideal candidate is a hands-on leader who coaches people as much as they fix processes. They will build a culture where every team member owns improvement, in a regulated medical device manufacturing environment.

Job Responsibilities:

Strategy and program leadership

  • 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 keep a visible portfolio of active work.
  • Set up and maintain the KPI framework (OEE, first-pass yield, scrap, on-time delivery, lead time, WIP) and tiered daily huddles.

Lean deployment on the floor

  • 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.

Problem solving and quality partnership

  • Lead structured root cause analysis (A3, 8D, 5 Whys, fishbone) on 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.

People and culture

  • 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; run Yellow Belt and Green Belt programs.
  • Set up and run an employee idea system with clear response times and recognition.
  • Manage and develop any CI specialists assigned to the team.

Results and reporting

  • 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.

Qualification Requirements:

  • Bachelor's degree in Industrial, Mechanical or Manufacturing Engineering, Operations Management, or a related field (or equivalent experience).
  • 7+ years in manufacturing operations or continuous improvement, including 3+ years leading improvement programs or people.
  • Lean Six Sigma Green Belt or higher.
  • Proven record of leading kaizen events and delivering measurable gains in quality, throughput, lead time or cost.
  • Strong data skills: Excel, Minitab or similar, and building KPI dashboards.
  • Clear communicator who can coach operators, influence supervisors and present to senior leaders.
  • Comfortable spending most of the day on the production floor.

Preferred 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 (e.g., SAP, Oracle) and production planning.
  • Background in high-mix, low-volume or cleanroom assembly.
  • Experience building a CI culture from the ground up or through a Lean transformation.
  • Bilingual English/Spanish.

Work environment:

This role splits time between the production floor and the office. It requires standing and walking for long periods, and wearing PPE or cleanroom gowning as required.

We are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or any other protected characteristic.

More information please go to www.baltgroup.com

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.

Pay Range

$130,000 - $150,000 USD

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