Manufacturing Engineer Job at Stark Pharma Solutions Inc in California

Overview

We are seeking a Manufacturing Engineer to support New Product Introduction (NPI) and ongoing manufacturing operations. The ideal candidate will act as the voice of operations in design and transfer projects, drive process improvements, and ensure manufacturing performance aligns with quality, safety, and productivity goals.

Details

• Job Title: Manufacturing Engineer
• Location: Fremont, CA
• Experience: 4 - 7 years
• Duration: 12+ Months

Key Responsibilities

• New Product Transfer
  • Serve as the Voice of Operations in NPI projects, including product transfer into manufacturing and quality operations.
  • Ensure requirements for Design for Manufacturability, Quality, Reliability, Safety, Serviceability, Cost, and overall robustness are incorporated throughout design and development.
  • Participate in all Design and Process FMEA exercises during design, development, and product transfer.
  • Identify technical risks and ensure they are mitigated prior to product launch.
• Manufacturing Support
  • Develop preventive and corrective maintenance routines for manufacturing equipment.
  • Schedule annual preventive maintenance based on cycles and MTBF, and implement calibration systems for critical equipment.
  • Improve automation in manufacturing processes and analyze cycle time, waste, and customer demand to optimize efficiency.
  • Support operations to achieve KPIs related to Safety, Quality, Delivery, and Productivity.
  • Participate in daily management activities, triage, and troubleshooting to improve productivity, first-pass yield, and reduce defective parts per unit.
• Process Validation and Sustaining Engineering
  • Author and execute validation protocols for new products, processes, and equipment upgrades (Installation Qualification, Operational Qualification, Performance Qualification, and Engineering Studies).
  • Document manufacturing activities, procedures, and process validations.
  • Assist supply chain in identifying alternative suppliers or components to mitigate risks associated with single/sole source or obsolescence.
  • Validate and qualify new suppliers or parts as needed.

Qualifications

• Bachelor's degree in Electrical, Mechanical, Industrial, or Manufacturing Engineering required.
• Minimum 4 years of experience in bioanalytical instrumentation manufacturing, consumables, and NPI/product transfer in a manufacturing engineering role.
• Experience with Six Sigma and Design for Six Sigma tools preferred.
• Proficient in Lean Manufacturing methods and tools; process efficiency and yield improvement experience.
• Excellent verbal and written communication skills; strong presentation abilities.

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