Sr. MFG Engineer, EDM

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.