Senior Manufacturing Engineer

Planet Pharma; Irvine (CA); On-site; USD 73,000 - 88,000; Full time

Job summary

Planet Pharma, Irvine, CA, seeks a Senior Manufacturing Engineer to lead cost, quality, safety, and business continuity initiatives in a regulated medical device manufacturing environment.

The role requires strong expertise in equipment and process validation (IQ/OQ/PQ) and Lean Six Sigma-driven improvements, with cross-functional collaboration across Product Development, Quality, Operations, and Regulatory teams.

Qualifications

• Experience developing and executing IQ/OQ/PQ protocols.
• Understanding validation requirements in a regulated manufacturing environment.
• Proven ability to lead cross-functional projects from planning through implementation.

Responsibilities

• Lead cost, quality, safety, and business continuity initiatives in a medical device manufacturing environment.
• Drive process improvements with validation activities and Lean Six Sigma methodologies.
• Collaborate with Product Development, Quality, Operations, Supply Chain, and Regulatory teams to enable transfer and commercialization of products.

Skills

IQ/OQ/PQ protocols

Cross-functional project leadership

Lean Six Sigma in medical devices

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

$53/hour - $64/hour W2 (Depending on previous experience)

Position Summary

We are seeking a highly motivated Senior Manufacturing Engineer to lead and support cost, quality, safety, and business continuity initiatives within a medical device manufacturing environment. This role is responsible for driving process improvements, leading validation activities, managing cross-functional projects, and optimizing manufacturing operations to improve efficiency, quality, and productivity. The ideal candidate will have strong project leadership experience, expertise in equipment and process validation, and a proven track record applying Lean Six Sigma methodologies in a regulated medical device production setting.

Key Responsibilities

• Lead cost, safety, service (business continuity), and quality improvement projects by managing project scope, budget, timelines, and resources to ensure successful implementation.
• Support manufacturing compliance initiatives related to cost reduction, quality improvement, safety enhancements, and operational continuity.
• Drive the innovation, development, optimization, and continuous improvement of existing manufacturing processes.
• Conduct feasibility assessments, equipment evaluations, material selection, and process development activities to optimize manufacturing performance.
• Lead tooling, fixture, and equipment installation projects, ensuring proper qualification and validation of manufacturing systems.
• Design manufacturing processes, production layouts, and operational workflows for assembly, machining, processing, equipment installation, and material handling applications.
• Develop and document sequences of operations, manufacturing procedures, and fabrication methods impacting product quality and performance.
• Provide technical support and sustaining engineering expertise for ongoing manufacturing operations.
• Recommend and implement equipment and process improvements to enhance quality, production efficiency, throughput, and yield.
• Review product development requirements to determine manufacturing compatibility, project costs, and implementation schedules.
• Collaborate closely with Product Development, Quality, Operations, Supply Chain, and Regulatory teams to ensure successful transfer and commercialization of products.
• Support continuous improvement initiatives utilizing Lean Manufacturing and Six Sigma methodologies.
• Lead equipment and process validation activities, including IQ/OQ/PQ protocols and execution within a regulated environment.

Required Technical Skills

Equipment and Process Validation

• Experience developing and executing IQ/OQ/PQ protocols.
• Strong understanding of validation requirements in a regulated manufacturing environment.

Project Management

• Proven experience leading cross-functional projects from planning through implementation.
• Ability to manage schedules, budgets, resources, risks, and deliverables.

Lean Six Sigma

• Experience applying Lean Manufacturing and Six Sigma principles within a medical device production environment.
• Demonstrated success driving process improvements and operational efficiencies.

Required Qualifications

Education

• Bachelor's degree in Engineering or a related technical discipline required.
• Advanced knowledge of manufacturing engineering principles typically obtained through advanced education and professional experience.
• For degrees earned outside the United States, degree requirements must satisfy applicable U.S. equivalency standards.
• Advanced degree preferred.

Experience

• Minimum of 4 years of relevant manufacturing engineering experience, OR Advanced degree with a minimum of 2 years of relevant experience.
• Experience within a medical device manufacturing environment strongly preferred.

Preferred Qualifications

• Medical device industry experience.
• Experience supporting regulated manufacturing environments (FDA, ISO 13485).
• Knowledge of risk management and process capability analysis.
• Experience with equipment qualifications, process validations, and continuous improvement programs.
• Lean Six Sigma Green Belt or Black Belt certification preferred.
• Strong analytical, communication, and problem-solving skills.