Manufacturing Engineer Resume
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Littleton, MA
SUMMARY
- Performance driven Mechanical Engineer with hi - tech capital equipment design and manufacturing knowledge. Detail oriented engineering professional experienced in medical device development within FDA regulated quality systems.
PROFESSIONAL EXPERIENCE
Confidential, Littleton, MA
Manufacturing Engineer
Responsibilities:
- Support manufacturing operations to lead product improvement goals for quality, reliability, yield and cost
- Generate, validate, and implement production procedures, tools and equipment for new generation capital product
- Provide system level technician support to resolve issues that arise on the manufacturing floor. Technical support includes diagnosing and resolving issues with mechanical components and electro/mechanical assemblies
- Identify root cause of manufacturing process and product nonconformities. Identify and implement necessary actions to correct and prevent reoccurrence
- Develop and structure BOMs and DHRs
Confidential, Littleton, MA
Associate Manufacturing Engineer
Responsibilities:
- Implemented manufacturing process developments- product synchronization, process flow, manufacturing line layout
- Developed and coordinated system level validations- improve reliability and repeatability by developing visual based work instructions and validating the process output
- Developed Device History Record for a 3-Dimensional X-ray System
- Lead the development of pFMEA for newly integrated manufacturing processes
- Designed calibration tool to be utilized in new generation imaging system. Collaborated with senior Ph.D imaging specialist to achieve design requirements for navigation, imaging, transportation, and functionality.
- Lead implementation of new process/ manufacturing improvements and trained manufacturing associates on new processes
- Utilized PLM software to update drawings, BOMs, and IPI forms for new generation mechanical assemblies
- Lead engineering change orders
Confidential, Amherst, MA
Co-Founder
Responsibilities:
- Collaborated with three classmates to design and prototype solar space heater that absorbs radiant solar heat and recycles transferred heat in a room or building. Consists of multiple patentable components
- Participated in MVP and VVM to progress business plan and market to targeted customers; gained mentorship and built contact base of experienced professionals in the renewable energy market
- Placed top three in two rounds of Innovation challenge (judges include legal experts, entrepreneurs, and IP consultants)
- Initial testing and data collection proved feasibility and functionality
TECHNICAL SKILLS
- Solidworks
- Equipment & Process Qualification DMAIC
- CMII/IPE
- Risk Assessments & Failure Analysis (FMEA)
- Product Lifecycle Management
- ISO 13485
- Medical Device Manufacturing
- Certified IPC Specialist (IPC-A-610)
- FDA 2 1CFR
- Microsoft (Word, Excel, etc.)
- Configuration Management