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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.