Sr. MFG Engineer, EDM Job at Bolt Medical, Carlsbad, CA

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  • Bolt Medical
  • Carlsbad, CA

Job Description

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

RECRUITERS: DO NOT CONTACT.

Role Description: The Senior Manufacturing Engineer will be a key contributor on Bolt’s Manufacturing team, developing a therapeutic medical device.

Responsibilities:

  • Evaluate existing EDM manufacturing practices , identifying areas for optimization and improvement .
  • Lead strategic operations to enhance production capacity and implement more efficient processes .
  • Analyze and design sequence of operations and workflows to maximize utilization of production facilities and personnel .
  • Oversee manufacturing process development, implementation, and continuous improvement to enhance yield, reduce costs, and improve productivity .
  • Lead Lean Manufacturing initiatives, including Value Stream Mapping, Kaizen events, and Six Sigma process improvement projects .
  • Apply Six Sigma methodologies ( DMAIC, DMADV ) using tools such as Minitab, FMEA, Fishbone diagrams, and Process Mapping . Black Belt certification preferred .
  • Optimize production processes to reduce inefficiencies and improve overall productivity .
  • Assess and refine operator tasks and responsibilities , identifying opportunities for workflow improvements and productivity enhancement.
  • Ensure accurate documentation of manufacturing processes, including technical reports, lab analyses, and data presentations .
  • Develop process improvements aimed at achieving high efficiency and cost-effectiveness .
  • Participate in projects focused on product quality enhancements, rework reduction, cost minimization, and performance improvements .
  • Analyze workflow layouts, equipment placement, and space utilization to maximize manufacturing efficiency .
  • Identify and resolve process-related issues to maintain high-quality production standards .
  • Provide daily production support , ensuring on-time delivery of top-tier products .
  • Assist in scaling up equipment and processes from prototype development to full-scale manufacturing .
  • Offer hands-on process guidance and training to operators , reinforcing technical best practices .
  • Troubleshoot production line challenges , addressing concerns related to yield, quality, and throughput .
  • Develop, verify, and validate manufacturing operations , ensuring seamless transition from process development to commercialization .
  • Lead fixture and tooling design initiatives to streamline manufacturing processes .
  • Utilize SolidWorks to design and fabricate fixtures/tooling for production improvement.
  • Apply principles of Design for Manufacturing (DFM), Design for Assembly (DFA), Design for Rework (DFR), Design for Six Sigma (DFSS), and Design for Supply Chain (DFSC) .
  • Ensure compliance with medical device industry standards , supporting commercialization efforts .
  • Operate EDMs, mills, and lathes ; familiarity with G-code is a plus.
  • Oversee and enhance automated visual inspection systems , including Keyence, Nikon, and OGP technologies .

Preferred Experience:

  • Proven experience in EDM manufacturing or similar machining environment
  • Proficiency in SolidWorks with expertise in 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 Biomedical, Mechanical, or Industrial engineering or a related field.

Required Experience:

  • 5+ years of equivalent industry experience and product development.
  • 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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