Air Horn
Saints Survivor
- Joined
- Jul 14, 2001
- Messages
- 425
- Reaction score
- 10
- Age
- 61
Offline
The Manufacturing Engineer will provide a depth of knowledge in the areas of medical device manufacturing for the company. This person will work closely with production and quality.
Summary of essential job functions
1. Act as the Manufacturing representative design and development of production processes including: quality control, inventory control, material and logistics flow, cost analysis.
2. Perform R&D on manufacturing processes including p-flow, machining and assembly methods, production equipment
3. Apply statistical methods to characterize, baseline and improve manufacturing processes from a quality and cost perspective Participate in design and process FMEA’s and Risk Analysis activities
4. Ensure that product conformance is met through product development and manufacturing to meet customer satisfaction
5. Perform time studies for establishing process standards and efficiencies and make improvements. Identify, prioritize and communicate process improvement opportunities
6. Review and approve engineering protocols and reports
7. Participate in activities to obtain ISO certifications
Minimum requirements
1. BS degree preferably in mechanical engineering
2. Five - ten years minimal experience working within a ISO 13485 and FDA 21 CFR Part 820 environment
3. Experience in working in a project team environment and represent manufacturing engineering on multi-functional teams
Abilities required
1. Strong verbal and written communication skills
2. Familiarization with Mini-Tab software a plus
3. Six Sigma certification preferred
4. Be able to interpret mechanical engineering design requirements, tolerances and methods of manufacturing to ensure reliability and confidence
5. Be able to conduct process validations (IQ/OQ/PQ and PPQ)
6. Experience in FMEA and Risk Analysis
7. DOE & Root Cause Analysis experience
8. Be able to troubleshoot procedures to address tool, equipment and process issues
9. Competent in MS Word, Excel. Competent in MS Project a plus
10. Familiarization with PPAP (Production Part Approval Process) a plus
Summary of essential job functions
1. Act as the Manufacturing representative design and development of production processes including: quality control, inventory control, material and logistics flow, cost analysis.
2. Perform R&D on manufacturing processes including p-flow, machining and assembly methods, production equipment
3. Apply statistical methods to characterize, baseline and improve manufacturing processes from a quality and cost perspective Participate in design and process FMEA’s and Risk Analysis activities
4. Ensure that product conformance is met through product development and manufacturing to meet customer satisfaction
5. Perform time studies for establishing process standards and efficiencies and make improvements. Identify, prioritize and communicate process improvement opportunities
6. Review and approve engineering protocols and reports
7. Participate in activities to obtain ISO certifications
Minimum requirements
1. BS degree preferably in mechanical engineering
2. Five - ten years minimal experience working within a ISO 13485 and FDA 21 CFR Part 820 environment
3. Experience in working in a project team environment and represent manufacturing engineering on multi-functional teams
Abilities required
1. Strong verbal and written communication skills
2. Familiarization with Mini-Tab software a plus
3. Six Sigma certification preferred
4. Be able to interpret mechanical engineering design requirements, tolerances and methods of manufacturing to ensure reliability and confidence
5. Be able to conduct process validations (IQ/OQ/PQ and PPQ)
6. Experience in FMEA and Risk Analysis
7. DOE & Root Cause Analysis experience
8. Be able to troubleshoot procedures to address tool, equipment and process issues
9. Competent in MS Word, Excel. Competent in MS Project a plus
10. Familiarization with PPAP (Production Part Approval Process) a plus