Lead and deliver multiple process improvement projects (Lean Six Sigma, DMAIC, Kaizen) that reduce cycle time, rework, and handoffs across product families and global sites.
Map, analyze, redesign, and standardize end-to-end workflows for critical processes with attention to detail needed to enable effective execution.
Establish pragmatic KPIs and dashboards, measure ROI for initiatives, and present results to functional leaders to secure sustained adoption.
Integrate risk-based thinking into process design to ensure compliance with 21 CFR 820, ISO 13485, ISO 14971 and other applicable regional regulations.
Use root-cause analysis, statistical analysis, and experiments to validate solutions; partner with data/BI resources to operationalize metrics.
Develop and deliver training, SOPs, and change management tactics for global rollouts; support local process adoption across sites and suppliers.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
8+ years experience in a regulated industry environment.
5+ years experience in medical device product development, quality systems, manufacturing, or process improvement.
Demonstrated experience leading multiple projects in a matrixed organization and influencing stakeholders at the director level.
Deep knowledge of medical device regulations (21 CFR 820, ISO 13485, ISO 14971).
Familiarity with Lean/Six Sigma methods; Green Belt or better preferred.
Strong data analysis and visualization skills (Excel, Power BI/Tableau); familiarity with PLM/QMS systems.
10% Domestic and/or international travel required.

Benefits

Health insurance
401(k) matching
Paid time off
Flexible work arrangements
Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Lean Six SigmaDMAICKaizenroot-cause analysisstatistical analysisdata analysisdata visualizationKPI developmentprocess improvementchange management

Soft Skills

leadershipinfluencing stakeholdersattention to detailcommunicationtraining developmentproject managementcollaborationproblem-solvingadaptabilityorganizational skills

Certifications

Green BeltLean Six Sigma certification