Manufacturing Process Engineer

International Association of Plumbing and Mechanical Officials (IAPMO); Sacramento (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

International Association of Plumbing and Mechanical Officials (IAPMO) is partnering with a Sacramento-area medical device contract manufacturer to hire a Manufacturing Process Engineer. The role focuses on establishing robust manufacturing processes, validation strategies, and qualifications for new products and processes.

You will collaborate with manufacturing, engineering and quality teams to drive process control, yield improvements and cost reductions in a cGMP environment.

Qualifications

• Bachelor's degree in Mechanical or Manufacturing Engineering, Science, or a related technical field.
• 10+ years of experience in a manufacturing environment.
• Strong background in process validation and qualification.
• Hands-on experience with silicone injection molding.
• Experience working within a medical device and cGMP-regulated environment.

Responsibilities

• Create and execute validation plans and protocols, with a focus on efficient manufacturing techniques
• Develop and implement Installation, Operational, and Performance Qualifications (IQ/OQ/PQ), along with Process Challenge testing, for equipment
• Perform trending and monitoring of critical quality attributes, critical process parameters to maintain product quality and control process drift
• Participate on project teams to start-up new product manufacturing, equipment or processes
• Develop routers, work instructions, SOPs and BOMs
• Participate on technical teams for deviation investigation resolution, equipment or process validation activities, training on new process technologies and on significant changes to manufacturing procedures
• Propose process improvement opportunities and /or corrective actions to increase yield, maximize production capacity, reduce product costs and decrease process variability while maintaining regulatory compliance.
• Implement process improvements to improve quality and cost.

Skills

Process validation

Silicone injection molding

Medical device industry

cGMP compliance

Mechanical engineering

Education

Bachelor's degree in Mechanical/Manufacturing Engineering or related field

Job description

Manufacturing Process Engineer - Medical Device Contract Manufacturing

We've partnered with a reputable medical device contract manufacturer, based in the Sacramento area, CA, that is looking to hire a Manufacturing Process Engineer to support its next phase of growth.

The company is a leading manufacturer of complex, high-performance components for the medical device industry, with deep expertise in injection molding, extrusion and assemblies. Having secured fresh PE investment to accelerate their continued growth, it's an exciting time to join the business.

Reporting to the Production Manager, you'll work closely with manufacturing, engineering and quality assurance to establish manufacturing processes and controls, meet production schedules, and drive process control and discipline across the site.

The role:

• Create and execute validation plans and protocols, with a focus on efficient manufacturing techniques
• Develop and implement Installation, Operational, and Performance Qualifications (IQ/OQ/PQ), along with Process Challenge testing, for equipment
• Perform trending and monitoring of critical quality attributes, critical process parameters to maintain product quality and control process drift
• Participate on project teams to start-up new product manufacturing, equipment or processes
• Develop routers, work instructions, SOPs and BOMs
• Participate on technical teams for deviation investigation resolution, equipment or process validation activities, training on new process technologies and on significant changes to manufacturing procedures
• Propose process improvement opportunities and /or corrective actions to increase yield, maximize production capacity, reduce product costs and decrease process variability while maintaining regulatory compliance.
• Implement process improvements to improve quality and cost.

What we're looking for:

• Bachelor's degree in Mechanical or Manufacturing Engineering, Science, or a related technical field
• 10+ years of experience in a manufacturing environment
• Strong background in process validation and qualification
• Hands-on experience with silicone injection molding
• Experience working within a medical device and cGMP-regulated environment