Job Description

Job Description

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

RECRUITERS: DO NOT CONTACT.

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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