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.
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Pay Range
$130,000-$150,000 USD
