32 Manufacturing jobs in Valley Center

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

Position Overview: The Sr. Manufacturing Supervisor coordinates and supervises the daily activities and sets priorities for the production team. Primarily in charge of ensuring the production line is operational and maintaining the ongoing production of products.

They are also responsible for troubleshooting any issues that arise, provide technical expertise for complex issues, ensures effective, and efficient production flow.

Responsibilities:

• Supervise and lead Production Assemblers
• In collaboration with department management and R&D, plans and executes the transfer of products from Research and Development into Manufacturing
• Identifies skill, knowledge and resource needs. Provides input to department management for workforce planning, staff development and performance management activities.
• Supervise and coordinate the activities of production and operations workers as assigned
• Assist line personnel in resolving job related problems
• Maintain an organized, safe, and efficient work area at all times
• Monitor work being produced to make sure it meets all specifications
• Monitor workflow and control output through work order distribution
• Ensure production goals are met
• Train assemblers on the proper use of work instructions
• Identifies training gaps and needs. Develops and delivers training to assemblers on the proper use of Manufacturing Instructions
• Sets work schedules and develops training schedules for new employees and evaluates performance
• Coordinate with Quality, Engineering, Shipping, and Manufacturing to deliver results
• Ensures that production personnel carry out all daily duties
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Support Manufacturing and Quality Engineers in product investigations
• Owns Capacity and Output tools if Manufacturing Line
• Collects and analyzes data, prepares, and presents reports and recommendations to improve production output and achieve business goals.
• Promotes team compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies.
• Support inventory counts by owning Work Order Open/Closing on ERP System

Qualifications:

Education:

• College Degree preferred or equivalent job experience required

Required Experience:

• 5+ years of supervising manufacturing production, operations experience in medical device, laboratory, diagnostics, or related industry experience.
• Demonstrated leadership abilities
• Good understanding of Current GMPs and ISO13485 standards.

Knowledge, Skills, and Abilities:

• Continual improvement process experience
• Strong communication and organizational skills
• A thorough understanding of Clean Room requirements
• Ability to create and adhere to effective schedules

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.

Organization Unit: Radiometer Pay Rate: 23/hr.

Primary responsibilities include:

1. Operate Hot Pouch Sealer.
2. Perform taping operations by hand.
3. Perform pouch filling operation.
4. Weighing filled pouches for proper liquid contents using a balance or a scale (ability to understand numeric weight range).
5. Manipulating filled pouch with hands or fixture to remove air bubbles.
6. Assembling a finished device.
7. Calibrating blood gas analyzers.
8. Perform pre-fill testing of sample solution on blood gas analyzer and documenting results (obtaining value information from analyzer).
9. Generating bar code labels.
10. Visually inspect parts according to quality criteria.
11. Perform final boxing of solution pack assembly.
12. Perform daily cycle counts of materials
13. Must be computer literate and have work experience using Excel.
14. Completion of routers.

Qualifications:
Must have a high school diploma. Minimum three years' experience in a production environment. Ability to perform repetitive work of high quality. Must be willing and able to perform involved process runs with minimal interruption and be detail oriented. QSR/GMP experience or previous training. Some experience with basic lab techniques such as micropipetting, pipetting, and weighing helpful. Experience at a medical device assembly firm preferred, but not required. Must be able to read, write and speak English. Must be able to follow written procedures and verbal instructions. Must be willing and able to conform to clean room practices with regard to apparel and personal hygiene.