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Position Overview: The Senior Manufacturing Engineer will support Engineering development and validation activities. This position will be a key contributor on Bolt’s Engineering team, developing a therapeutic medical device.
Responsibilities: • Working understanding of statistics for process development including sample size selection, data distribution analysis, process capability, Design of Experiments (DOE), and Analysis of Variance (ANOVA).
• Working understanding of inspection methods and procedures (Test Method Validation). • Demonstrate strong problem-solving skills and have the ability to ask critical questions without being the subject matter expert.
• Interact with Product Development/R&D to ensure that processes and designs are manufacturable.
• Design manufacturing processes, procedures and production layouts for assemblies, equipment installation and material handling.
• Strong fixture design and development skills including mechanical design, tolerance analysis and material selection.
• Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost, and improve productivity.
• Experience using Six Sigma Methodology (DMAIC) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.
• Initiate and lead lean manufacturing process improvement projects for high efficiency and cost effectiveness.
• Maintain process and manufacturing documents.
• Experience in documenting technical work and results, writing lab reports, and analysis / presentation of data.
• Participate in process improvement projects to improve product quality, reduce rework / scrap, decrease cost, and improve product performance.
• Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency.
• Assist in scaling up equipment and processes from prototypes to pilot to full scale manufacturing.
• Demonstrate hands-on process understanding and provide guidance and training to operators.
• Troubleshoot production line issues related to yield, quality, and throughput.
• Develop, verify, and validate manufacturing operations from process development to successful commercialization.
• Manage and perform design verification, equipment qualification and product and process validations.
Preferred Experience:
• Fixture and tooling design to assist with manufacturing needs and process improvements
• Proficient with SolidWorks to support fixture / tooling design and fabrication
• Experience with DFM (Design for Manufacturing), DFA (Assembly), DFSS (Six Sigma)
• Experience with the Medical Device Industry and the industry requirements to bring products into commercialization.
Qualifications:
Education: Bachelor’s Degree or master’s degree in Mechanical ,Biomedical, or Industrial Engineering.
Required Experience: • 5+ years of equivalent industry experience.
• Good understanding of Current GMPs and ISO 13485 standards.
• Manufacturing or sustaining experience.
Knowledge, Skills, and Abilities:
• Strong communication and organizational skills.
• Continual improvement process experience.
• Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment.
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