Senior Process Engineer, Manufacturing (Cincinnati, OH, US, 45241) at Enable Injections | High-Volume Wearable Drug Delivery Systems

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