Manufacturing Engineer II (Carlsbad)

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 resultsoriented attitude.