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QUALIFICATIONS
Required:
- Bachelor’s Degree in a technical discipline (e.g. Engineering or Science) and/or equivalent education/experience
- 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
Preferred:
- Experience in a high-volume FDA regulated commercial manufacturing environment
- Lean Six Sigma Green or Black Belt Certification (LSSGB/LSSBB)
Skills & Competencies:
- Attention to detail and commitment to quality
- Excellent verbal communication and technical writing skills
- Ability to troubleshoot equipment and processes using advanced techniques (5 Why’s, Fishbone Diagram, DOE, etc.)
- Strong knowledge and application of automation: vision systems, robotics, and PLCs
- Strong understanding and application of statistical techniques for process and equipment performance evaluation
- 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)
- Ability to independently plan and carry out multiple projects concurrently
- Strong ability to analyze complex problems and implement solutions effectively
- Ability to foster teamwork, collaboration, negotiation, and influencing others across departments
- Ability to quickly adapt to diverse and changing business needs, conditions, and opportunities
- Ability to understand and influence based on broader business dynamics
- Strong time management skills and ability to manage competing priorities
- Ability to mentor and positively impact others in support of company goals and a healthy work environment
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.
- Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time
- Position requires being physically present on the premises during regular company hours or as approved by management
RESPONSIBILITIES
- Manufacturing Support: Respond rapidly to downtime events and lead efforts to bring production back online as quickly as possible
- Continuous Improvement: Identify opportunities to improve yield/throughput/labor and independently lead implementation
- 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: Lead product/process/equipment investigations with cross-functional teams
- Production Model: Create and maintain labor/capacity/yield models for manufacturing lines
- Engineering Builds: Lead equipment/process development builds and tests; write protocols and engineering reports to summarize activities
- Training: Act as approved trainer and mentor for manufacturing operators and junior engineers
- Layout/Workflow: Independently determine and lead optimization of layouts and workflows using lean methodologies
- Other duties as assigned
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