Job Summary
The Manufacturing Engineer I 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 I 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:
- 0-2 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.
Job Type: Full-time
Pay: $70,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Ability to Commute:
- Carlsbad, CA 92008 (Required)
Ability to Relocate:
- Carlsbad, CA 92008: Relocate before starting work (Required)
Work Location: In person
