Senior Manufacturing Engineer

Lumicity; Berkeley (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Lumicity in Berkeley, CA seeks a Senior Manufacturing Engineer to ensure reliability, quality, scalability and cost efficiency of a minimally invasive medical device product line. You will partner with Quality, R&D, Supply Chain and CMOs to resolve manufacturing challenges, drive improvements, support validation, and assure regulatory compliance.

Responsibilities include monitoring performance, improving yields, implementing CAPA, and leading DFMs and process transfers with internal teams and

Qualifications

• Minimum 5 years of manufacturing engineering experience in the medical device industry or another highly regulated industry.
• Experience supporting product development, process development, manufacturing scale-up, and product commercialization.
• Demonstrated success working directly with external manufacturing partners on process transfers, validation, and continuous improvement initiatives.
• Strong technical writing skills with experience creating manufacturing, validation, and quality documentation.
• Proven ability to collaborate effectively across multiple functional teams and external suppliers.

Responsibilities

• Collaborate with Manufacturing Engineering and R&D teams to develop and implement manufacturing equipment and process improvements.
• Analyze, troubleshoot, and optimize manufacturing processes to improve product quality, efficiency, and yield using Lean Manufacturing and Six Sigma methodologies.
• Utilize statistical tools and data analysis techniques to monitor process performance and identify opportunities for improvement.
• Partner with contract manufacturing organizations (CMOs) to enhance production output, quality, and operational efficiency.
• Provide Design for Manufacturability (DFM) recommendations to support new product development and manufacturing readiness.
• Support and oversee external manufacturing and supplier operations, including domestic and international partners.
• Lead product failure investigations using structured problem-solving methodologies such as Root Cause Analysis, FMEA, and 8D.
• Develop and implement corrective and preventive actions (CAPA) to address manufacturing and quality issues.
• Support complaint investigations, risk assessments, labeling updates, and product change evaluations as required.
• Identify and execute cost reduction opportunities while maintaining compliance and product quality standards.
• Participate in cross-functional engineering projects focused on manufacturing process improvements and product enhancements.
• Develop training materials and provide technical training for manufacturing personnel, technicians, inspectors, and engineers.
• Support process validation, equipment qualification, manufacturing transfers, and process monitoring activities at supplier and manufacturing partner sites.
• Generate and maintain manufacturing documentation, validation protocols, reports, work instructions, and engineering records.

Skills

Lean Manufacturing

Six Sigma

Data analysis

Root Cause Analysis

FMEA

CAPA

Process improvement

Documentation

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in Mechanical Engineering

Job description

Travel Requirements: Frequent travel to Santa Rosa, CA manufacturing facilities

Position Summary

The Senior Manufacturing Engineer is responsible for supporting the reliability, quality, scalability, and cost-effectiveness of a minimally invasive medical device product line. This role partners closely with Quality, Research & Development, Supply Chain, and contract manufacturing partners to resolve manufacturing challenges, drive continuous improvement initiatives, support validation activities, and ensure compliance with applicable regulatory and quality system requirements. Responsibilities include monitoring manufacturing performance, improving yields, implementing corrective actions, and supporting product lifecycle management activities.

Key Responsibilities

• Collaborate with Manufacturing Engineering and R&D teams to develop and implement manufacturing equipment and process improvements.
• Analyze, troubleshoot, and optimize manufacturing processes to improve product quality, efficiency, and yield using Lean Manufacturing and Six Sigma methodologies.
• Utilize statistical tools and data analysis techniques to monitor process performance and identify opportunities for improvement.
• Partner with contract manufacturing organizations (CMOs) to enhance production output, quality, and operational efficiency.
• Provide Design for Manufacturability (DFM) recommendations to support new product development and manufacturing readiness.
• Support and oversee external manufacturing and supplier operations, including domestic and international partners.
• Lead product failure investigations using structured problem-solving methodologies such as Root Cause Analysis, FMEA, and 8D.
• Develop and implement corrective and preventive actions (CAPA) to address manufacturing and quality issues.
• Support complaint investigations, risk assessments, labeling updates, and product change evaluations as required.
• Identify and execute cost reduction opportunities while maintaining compliance and product quality standards.
• Participate in cross-functional engineering projects focused on manufacturing process improvements and product enhancements.
• Develop training materials and provide technical training for manufacturing personnel, technicians, inspectors, and engineers.
• Support process validation, equipment qualification, manufacturing transfers, and process monitoring activities at supplier and manufacturing partner sites.
• Generate and maintain manufacturing documentation, validation protocols, reports, work instructions, and engineering records.

Education

• Bachelor's degree in Mechanical Engineering or a related technical discipline.

Experience

• 5+ years of manufacturing engineering experience within the medical device industry or another highly regulated industry.
• Experience supporting product development, process development, manufacturing scale-up, and product commercialization.
• Demonstrated success working directly with external manufacturing partners on process transfers, validation, and continuous improvement initiatives.
• Strong technical writing skills with experience creating manufacturing, validation, and quality documentation.
• Proven ability to collaborate effectively across multiple functional teams and external suppliers.