QUALIFICATIONS

Required:

• Bachelor’s Degree in a technical discipline (e.g. Engineering or Science) and/or education/experience equivalent
• A minimum of 6 years of experience in FDA regulated manufacturing and/or process/equipment/product development.
• Strong experience leading cross functional teams, projects, and/or direct reports
• Experience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testing
• Experience in a high-volume FDA regulated commercial manufacturing environment

Preferred:

• Lean Six Sigma Green or Black Belt Certification (LSSBB/GB)

Skills & Competencies:

• Ability to troubleshoot equipment and processes. Utilize investigation techniques (5 Why’s, Fishbone Diagram, etc.)
• Strong knowledge and understanding of automation: vision systems, robotics, and Programmable Logic Controllers
• Strong understanding of application of statistical techniques for evaluation of process and equipment performance
• Strong understanding and application of 21 CFR 820 Medical Device Quality System Regulation relevant to manufacturing support
• Proficient with the MS Office Suite (Word, PowerPoint, Excel, Visio)
• CAD design and drafting (Solidworks preferred)
• Strong influencing and negotiating skills (for lead/sr role)
• Excellent verbal communication and technical writing skills
• Attention to detail

Physical Requirements:

• Must be able to stand in a stationary position for extended periods of time
• Ability to operate a computer and other office equipment for extended periods of time
• Ability to lift 50 lbs.

RESPONSIBILITIES:

• Manufacturing Support: Respond rapidly to downtime events and determine the course of action to bring production back online as quickly as possible.
• Continuous Improvement: Identify opportunities to improve yield/throughput/labor. Lead the effort to implement the improvement.
• Quality System documentation: Author quality system documents such as nonconformance reports (NCR), corrective and preventive action plans (CAPA), change controls (CC), sort/rework instructions. Present documents at cross functional review boards. Author/revise procedures via document change orders (DCO). Author/revise routers as documents or data in SAP.
• Root Cause Investigations: Lead product/process/equipment root cause investigations with the support of a cross functional team. Determine scrap root cause based on product/process knowledge.
• Production Model: Create and maintain the labor/capacity/yield production model for manufacturing lines.
• Engineering Builds: Lead equipment/process development engineering builds and tests. Write protocols and engineering reports to summarize activity
• Training: Act as approved trainer for the manufacturing operators
• Layout/Workflow: Determine and lead efforts to optimize layouts and workflows using lean methodologies.
• Other duties as assigned.