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Engineering Specialist
2 months ago
Overview:
An established Medical Device company focused on Class 2 & 3 devices is looking to add an Engineer with a Quality and Manufacturing background to serve as a multi-site engineering specialist. With lofty growth projections and an already dominant market share, the ideal candidate must have experience leading continuous improvement projects through the use of lean engineering methodologies.
Essential Duties:
- Continuously enhance product quality and services by aligning QMS processes with evolving business needs and creating new procedures.
- Ensure project sustainability.
- Lead and direct cross-functional teams in Lean and continuous improvement efforts. Supervise Six Sigma training, perform audits, and support digital transformation initiatives.
- Act as a technical advisor, address complex challenges, and mentor junior engineers. Work closely with key stakeholders, manage risks effectively, and maintain compliance across all functions.
Minimum Qualification Requirements:
Education:
- Bachelor’s degree in Business Management, Engineering, or a related field, or equivalent education and experience sufficient to perform the job’s essential functions.
Experience:
- At least 8 years of experience in business operations, plant manufacturing, or engineering, including 3 years of demonstrated success in process improvement programs.
- At least 2 years of GMP manufacturing experience is required. Knowledge of FDA regulatory and ISO requirements and trends affecting medical devices and drug combination products is preferred.
- Black Belt LEAN/Six Sigma certification is required or must be obtained within the first year.
- Proficiency in Microsoft Teams, Excel, PowerPoint, Minitab (required), and Power BI (preferred).
