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Senior Manufacturing Engineer

4 months ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.


Essential responsibilities:

· Evaluate current catheter manufacturing practices and identify those needing improvement.

· Lead operations to increase production capacity and implement new efficient processes.

· Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel

· Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost, and improve productivity.

· Experience using Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events

· Experience using Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc. Black Belt preferred.

· Initiate and lead lean manufacturing process improvement projects

· Improve the efficiency to each production process.

· Evaluate operators’ tasks and responsibilities, identifying process improvements or tools to improve productivity.

· Maintain process and manufacturing documents.

· Experience in documenting technical work and results, writing lab reports, and analysis / presentation of data.

· Develop process improvements for high efficiency and cost effectiveness.

· 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.

· Identify and troubleshoot process-related issues.

· Support daily production to ensure on-time delivery of top-quality products.

· 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.

· Perform or manage design verification, equipment qualification and product and process validations.

· 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), DFR (Rework), DFSS (Six Sigma), and DFSC (Supply Chain)

· Experience with the Medical Device Industry and the industry requirements to bring products into commercialization.

Required Knowledge and Experience:

· Bachelor’s Degree or master’s degree in biomedical, Mechanical, or Industrial engineering or a related field.

· 7+ years of equivalent industry experience and product development.

· Good understanding of Current GMPs and ISO 13485 standards.

· Manufacturing or sustaining experience.

· Strong communication and organizational skills.

· Continual improvement process experience.

· Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment.