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Manufacturing Engineer II

Manufacturing Engineer II

Bolt MedicalCarlsbad, CA, US
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Job Description

Position Overview :

The Manufacturing Engineer II plans and designs manufacturing processes for a production facility. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Being a Manufacturing Engineer II determines the parts, equipment, and tools needed to achieve manufacturing goals according to product specifications.

Responsibilities :

  • Evaluate current catheter manufacturing practices and identify those needing improvement.
  • Lead operations to increase production capacity and implement new efficient processes.
  • Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel.
  • Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events.
  • Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.
  • Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity.
  • Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing.
  • Performs or manages process validations (IQ, OQ, PQ).
  • Troubleshoot production line issues related to yield, quality, and throughput.
  • Leads scaling up processes from development to full scale manufacturing.
  • Supports evaluation of NCR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers / Suppliers.
  • Creates / Updates manufacturing instructions, routings, bills of materials and SOPs.

Qualifications : Education :

  • Engineering degree desired or equivalent experience in related job field.

    • Required Experience :

  • 2+ yrs Biomedical product or medical device development experience.
  • Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
  • Proficient in CAD software, preferably SolidWorks.
  • Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
  • Hands-on experience managing suppliers and / or contract manufacturers a plus.
  • Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred.

    • Knowledge, Skills, and Abilities :

  • Knowledge of ASME Y14.5 GD&T.
  • Excellent interpersonal, communication, and documentation skills are required.
  • Takes initiative and acts quickly to drive solutions.
  • Strong interpersonal, organizational and communication skills.
  • A flexible team player, focusing on shared goals with a positive results‐oriented attitude.
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