Principal Manufacturing Engineer

Planet Pharma; Draper (UT); On-site; USD 71,635 - 85,411; Full time

Job summary

Planet Pharma seeks a Principal Manufacturing Engineer to lead metals manufacturing and drive validation, troubleshooting, and continuous improvement across production. You will elevate process capability, quality, yield, and equipment performance in a medical device context.

Responsibilities include leading qualification projects, applying Lean/Six Sigma, and developing detailed documentation while ensuring compliance with EHS and cleanroom standards.

Qualifications

• Bachelor’s degree in engineering required.
• 8+ years experience required.
• Experience with metals manufacturing processes and validation.

Responsibilities

• Provide technical support for metals manufacturing processes, equipment, tooling, and inspection methods.
• Lead equipment qualification, validation, and production support projects.
• Design, document, and qualify studies, protocols, and reports to improve processes.
• Implement Lean, Six Sigma, root cause analysis, and risk-based methods.
• Analyze and resolve manufacturing and compliance issues (CAPAs, nonconformances).
• Develop work instructions, validation documents, and training materials.
• Plan and execute projects to meet schedules and stakeholder expectations.
• Ensure compliance with EHS, quality systems, and cleanroom requirements.
• Study time, motion, methods to improve efficiency and standard production rate.

Skills

Manufacturing engineering

Process optimization

Lean Six Sigma

Root cause analysis

Statistical analysis

Project management

Documentation & reporting

Leadership

Communication

Microsoft Office

Education

Bachelor's degree in engineering

Job description

Target PR Range: 52-62/hr DOE

Summary

The Principal Manufacturing Engineer will provide technical leadership for metals manufacturing processes supporting medical device component production. This role will lead validation, troubleshooting, and continuous improvement activities across manufacturing operations. The engineer will apply advanced engineering principles to improve process capability, quality, yield, efficiency, equipment performance, and manufacturability.

Job Responsibilities

• Provide technical support for metals manufacturing processes, equipment, tooling, fixtures, inspection methods, and production documentation.
• Lead complex manufacturing engineering projects, including equipment/process qualification, validation, and production support.
• Design, execute, and document engineering studies, experiments, protocols, and technical reports to qualify or improve manufacturing processes.
• Identify and implement process improvements using Lean, Six Sigma, root cause analysis, statistical analysis, and risk-based engineering methods.
• Analyze and resolve complex manufacturing and compliance issues, including CAPAs, nonconformances, audit observations, process excursions, and yield issues.
• Develop and revise work instructions, process documentation, training materials, validation documents, and technical reports.
• Lead project planning and execution to ensure technical deliverables are completed on schedule and meet stakeholder expectations.
• Support compliance with applicable EHS, quality system, and cleanroom medical device manufacturing requirements.
• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.

Skills

• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Strong technical expertise in manufacturing engineering and process optimization.
• Experience with metals manufacturing processes, equipment, tooling, fixtures, and inspection methods.
• Advanced problem-solving, analytical, organizational, and critical-thinking skills.
• Ability to lead complex engineering studies, validations, investigations, and improvement projects.
• Ability to translate complex technical information for production teams, technical partners, and leadership.
• Ability to manage competing priorities in a fast-paced manufacturing environment.
• Strict attention to detail and strong commitment to quality, safety, and compliance.
• Proficiency with Microsoft Office
• Experience with Lean, Six Sigma, process validation, risk analysis, and project management tools preferred.

Education/Experience

• Bachelor’s degree in engineering required.
• 8+ years experience required.