Enable Injections Inc
Senior Process Engineer, Manufacturing
Enable Injections Inc, Cincinnati, Ohio, United States, 45208
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
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