Senior Production Engineer, Manufacturing

Enable Injections Inc.•Sharonville, OH

18d•Onsite

About The Position

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

Requirements

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
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
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

Nice To Haves

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

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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