Sr. Process Engineer

Job Title

Sr. Process Engineer

Job Description
(Define At least 6 points which candidate is supposed to do)

• Degree in Mechanical, Materials Engineering with minimum 4 years of experience
• Manufacturing Engineering experience in Medical Devices.
• Well versed in Crimping Process (Laser Cutting/Welding is a plus), Fixture Design and Troubleshooting and familiar with Medical Device Design Controls
• Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations.
• Design and develop equipment and fixture requirements and its process parameters where applicable. Work with suppliers and internal stakeholders to realize design and ensure it meets specified requirements.
• Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Develop plans to evaluate process capability.
• Perform test method development and validation.
• Defines and generates all required documentation in support of manufacturing products and processes including designing and writing engineering protocols in compliance with GMPs and internal procedures, FMECAs, reports, manufacturing instructions and procedures.
• Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary.
• Provides in depth analysis of issues or problems and implements process improvements to enhance performance of the job area.
• Engineering Build Coordination across multiple sites. Need to coordinate build plans with R&D, PD & Manufacturing. Must be organized and good communicator.

Positions based at (Client location with Zip code)

Toledo Way, Irvine, California, United States

Project Code

N/A

Work Authorization (Citizen/GC/H1B/Either)

Valid Work Permit/Visa is required

Key word to search

1. Crimping Process (Laser Cutting/Welding is a plus)
2. Fixture Design and Troubleshooting
3. Familiar with Medical Device Design Controls
4. Equipment Qualification
5. Process Validation
6. Engineering Protocols & Reports

Mandatory Skills

Technical / Soft Skills

Expertise Level (Expert / Good / Knowledge)

Remarks

Higher class Medical Device product Supplier qualification

Good

Hands On experience

Risk Management ISO14971

Good

Hands On experience

Supplier Audit

Good

Hands On experience

Desired Skills

Technical / Soft Skills

Expertise Level (Expert / Good / Knowledge)

Remarks

ISO 13485 Medical Device Quality Management system

Good

Hands On experience