What are the responsibilities and job description for the Manufacturing Engineer position at Robling Medical?
Job Details
Summary:
The Manufacturing Engineer is responsible for supporting transfer to manufacturing activities and sustaining & improving ongoing manufacturing processes. This is a key critical role in the validation & maintenance of robust processes, assembly tools & methods, manufacturing processes, etc. This position requires 1) technical expertise in validation, process improvement & implementation activities for associated materials, components, assemblies, processes, tooling/fixtures, & equipment; 2) communicating with customers, vendors, & various project teams; 3) report preparation for project status & validation activities; 4) assisting the Engineering team with the development cost-effective & efficient processes; 5) participation on a team that ensures robust processes are ready for transfer to the Robling Medical manufacturing environment on time.
Primary Duties and Responsibilities
- Technical and hands-on leadership in following:
- MFG Line Design & Setup Leadership
- MFG Efficiencies Monitoring, Evaluation/Analysis, Improvement
- Equipment and Process Validation - Protocol Development, Execution, and Report Writing
- Root Cause Analysis in Support of CAPAs, NMRs, etc.
- Evaluation, scoping, budgeting, execution, and Reporting of process improvements and cost reductions
- Participation in the management of the company Calibration Program
- Equipment & Tooling Control Program Management
- XFER to MFG - Initial Release, Training, Line Setup, Life Cycle Support
- Assistance with Development of Manufacturing Documentation (DMR, Work Instructions, BOMs, Routers and etc.)
- Assistance with Maintenance Troubleshooting & PM Program Management
- Assistance with Process Development Activities
- Assistance with Design for Manufacturing
- Assistance with Package Development and Qualifications
- Assistance with Test Method Development and Qualification
- Assistance with Tooling & Fixture Design and Qualification
- Risk Analysis Support (pFMEA)
- Ensures manufacturing processes remain in compliance with ISO and FDA regulations.
Required Qualifications
- 4-year degree in an Engineering field (Biomedical, Mechanical, Industrial or Electrical) or equivalent combination of 4-year degree & applicable experience with at least 2 years of experience in the field. Applicable internship experience may also be considered.
- DOE design and execution
- Validation protocol generation, execution, & report writing
- Experience in developing & maintaining pFMEAs
- Strong project management skills
- Excellent interpersonal skills & written communication
- Strong analytical skills & attention to detail
- Highly motivated self-sta1ier with ability to drive for results
- Demonstrate ability to effectively organize, prioritize & accomplish multiple tasks; makes decisions & solves problems independently
- Experience in a fast-paced environment where 'speed to market" is identified as a key performance indicator
- Strong computer skills (MS Word, Excel, PowerPoint, Outlook, Project Management Tools,CAD, Statistical Software, Graphic Design Tools)
Preferred Qualifications:
Experience in an ISO 9001 or ISO 13485 manufacturing environment
- Medical Device or Pharmaceutical development or manufacturing experience
- Experience with sterile packaging & terminal sterilization processes such as EtO, Gamma, etc.
- Technical skills in manufacturing processes & methods including flow, layout, assembly & production equipment
- Cross-discipline engineering experience
- Demonstrated ability to lead & manage a team
- Experience in troubleshooting & repairing equipment
- Experience with heat sealing, vacuum forming, RF welding, high speed packaging lines, adhesive dispensing systems, cutting/punching/skiving/forming thermoplastics, inspection & test equipment (leak testing, scales, force gauges, etc.)
- Lean Six Sigma Green Belt Certification
- Experience with MiniTab
- Experience with SolidWorks
- Experience with electro-mechanical devices & equipment (design, fabrication/assembly, installation, qualification, operation)
Environment & Working Conditions:
This position is generally performed indoors in a plant or office environment and requires specific physical requirements that must be met, including:
- Some heavy lifting and considerable moving of equipment(lifting up to 50pounds)
- Standing for long periods of time
- Sitting for long period of time
- Bending and ability to reach with hands &arms
- Visual - constant visual attention (i.e., color vision, depth perception, ability to adjust focus).
Salary : $72,655 - $96,017