Manufacturing Engineer

3PE; Fontana (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

3PE is looking for a professional to manage manufacturing processes and drive product development. This role involves collaborating with R&D and Engineering, ensuring compliance with FDA regulations, and developing documentation for manufacturing.

Qualified candidates should have knowledge of medical device materials and manufacturing processes. The position promises an engaging work environment that focuses on innovation and quality standards in medical products.

Qualifications

• Knowledge of materials related to medical devices.
• Knowledge of medical manufacturing processes.
• Experience in process validation and risk analysis.

Responsibilities

• Manage product development improvements and training in a pilot or production setting.
• Lead the development of manufacturing processes for new products.
• Comply with FDA and international regulatory standards.
• Develop manufacturing documentation and qualifications for tooling/equipment.
• Work with outside suppliers and departments.

Skills

Knowledge in materials associated with medical devices

Knowledge in processes associated with medical manufacturing

Proficient in design and process FMECA/FMEA/Hazards Analysis/Risk Analysis

Proficiency with programming languages (g-code, CO++, VB)

Job description

Pacific PPE Corporation specializes in the development and manufacture of ergonomically designed respirators using top quality materials and automated processes. The company's focus is on bringing the best quality respirators and masks to the public at affordable prices. All of Pacific PPE's products have passed the FFP2 grade respirator tests at BSI. www.3peco.com

Job Description

• Manage required builds for existing product development improvements/new product development in a pilot or in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, and troubleshooting assembly issues.
• Provide manufacturing capacity analysis of existing product lines.
• Lead the development of highly capable manufacturing processes for new existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
• Develop and coordinate the execution of process characterization and validation plans.
• Comply with applicable FDA and international regulatory laws/standards.
• Lead/support production line in non-conformance investigations and dispositions.
• Development of manufacturing documentation (MP, Traveler, BOM).
• Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
• Design and implement custom equipment/tools, fixtures and/or off the shelf equipment/tools, fixtures for highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
• Work with outside OEM Suppliers, internal/external machine shops and or other departments/groups.
• Application of statistical and analytical methods such as SPC, SQC, and DOE.
• Participation on project teams tasked with new process/product development and the successful transfer into manufacturing.
• Process background (development, capability, optimization, validation) within a regulated industry.
• Other duties as assigned or required.

Qualifications

• Knowledge in materials associated with medical devices.
• knowledge in processes associated with medical manufacturing.
• Proficient in design and process FMECA/FMEA/Hazards Analysis/Risk Analysis, Process Validation, and variability reduction applications.
• Proficiency with program languages such as (g-code, CO++, VB etc.) but not required.

Additional Information

PHYSICAL DEMANDS – Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential physical demands:

• Physically able to sit, stand and walk for extended periods of time.
• Able to move about on foot; walk up and down stairs repeatedly as needed.
• Clarity of vision at 20 inches or more; able to view a computer monitor for extended periods of time.

All your information will be kept confidential according to EEO guidelines.