Job Description

Location: Onsite

Status Type: Full Time

QUALIFICATIONS

Required:

• Bachelor’s Degree in a technical discipline (e.g. Engineering or Science) and/or equivalent education/experience
• Minimum of 4 years of experience in FDA regulated manufacturing and/or process/equipment/product development
• Beginning 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

Preferred:

• Experience in a high-volume FDA regulated commercial manufacturing environment
• Lean Six Sigma Green or Black Belt Certification (LSSBB/GB)

Skills & Competencies:

• Strong attention to detail and commitment to quality
• Excellent verbal communication and technical writing skills
• Ability to troubleshoot equipment and processes using investigation techniques (5 Why’s, Fishbone Diagram, etc.)
• General knowledge and understanding of automation: vision systems, robotics, and PLCs
• 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 or AutoCAD design and drafting skills
• Ability to plan and carry out sequential projects independently
• Ability to analyze problems and troubleshoot solutions effectively
• Ability to foster teamwork, collaboration, negotiation, and influencing others at the project team level
• Ability to adapt behaviors and activities during times of change and handle unexpected situations with minimal guidance
• Exemplifies flexibility and resourcefulness in responding to challenges and opportunities
• Strong time management skills and ability to manage multiple priorities
• Ability to maintain a positive attitude, show empathy for others, and act with integrity in support of company goals and a healthy work environment

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment
• Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time
• Ability to lift 50 lbs

RESPONSIBILITIES:

• Manufacturing Support: Respond rapidly to downtime events and support efforts to bring production back online as quickly as possible
• Continuous Improvement: Identify opportunities to improve yield/throughput/labor and begin leading implementation with guidance
• Quality System Documentation: Author documents such as NCRs, CAPAs, change controls, and rework instructions; present at cross-functional review boards; author/revise DCOs and routers in SAP
• Root Cause Investigations: Support product/process/equipment investigations with cross-functional teams
• Production Model: Create and maintain labor/capacity/yield models for manufacturing lines
• Engineering Builds: Support development builds; write engineering reports to summarize builds
• Build Protocols and Reports: Author build protocols and reports
• Training: Act as approved trainer for manufacturing operators
• Layout/Workflow: Participate in efforts to optimize layouts and workflows using lean methodologies
• Other duties as assigned