What are the responsibilities and job description for the Senior Process Engineer, Manufacturing position at Enable Injections, Inc.?
Title: Senior Process Engineer, Manufacturing
Description
QUALIFICATIONS
Required
Description
QUALIFICATIONS
Required
- Bachelor’s Degree in a technical discipline (e.g. Engineering or Science) and/or education/experience equivalent
- A 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
- Experience in a high-volume FDA regulated commercial manufacturing environment
- Lean Six Sigma Green or Black Belt Certification (LSSBB/GB)
- Ability to troubleshoot equipment and processes. Utilize investigation techniques (5 Why’s, Fishbone Diagram, etc.)
- Strong knowledge and understanding of automation: vision systems, robotics, and Programmable Logic Controllers
- Strong understanding of application of statistical techniques for evaluation of process and equipment performance
- 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)
- Strong influencing and negotiating skills (for lead/sr role)
- Excellent verbal communication and technical writing skills
- Attention to detail
- 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.
- Manufacturing Support: Respond rapidly to downtime events and determine the course of action to bring production back online as quickly as possible.
- Continuous Improvement: Identify opportunities to improve yield/throughput/labor. Lead the effort to implement the improvement.
- Quality System documentation: Author quality system documents such as nonconformance reports (NCR), corrective and preventive action plans (CAPA), change controls (CC), sort/rework instructions. Present documents at cross functional review boards. Author/revise procedures via document change orders (DCO). Author/revise routers as documents or data in SAP.
- Root Cause Investigations: Lead product/process/equipment root cause investigations with the support of a cross functional team. Determine scrap root cause based on product/process knowledge.
- Production Model: Create and maintain the labor/capacity/yield production model for manufacturing lines.
- Engineering Builds: Lead equipment/process development engineering builds and tests. Write protocols and engineering reports to summarize activity
- Training: Act as approved trainer for the manufacturing operators
- Layout/Workflow: Determine and lead efforts to optimize layouts and workflows using lean methodologies.
- Other duties as assigned.
