Pilot Operations & Quality Engineering Lead (Medical Devices)

Planet Pharma; Irvine (CA); On-site; USD 66,000 - 80,000; Full time

Job summary

Planet Pharma in Irvine, CA is seeking a Pilot Operations Senior Quality Engineer to partner on validation activities for an introducer sheath used in THV devices. This role applies IQ/OQ/PQ knowledge and quality engineering methods to ensure regulatory compliance and reliable device delivery to patients.

Responsibilities include creating validation strategies, reviewing PFMEAs, developing training materials for production, and coordinating technicians.

Qualifications

• Bachelor’s Degree in Engineering or related field with at least 4 years of industry experience required.
• Master’s Degree or PhD preferred depending on level.
• Certifications CQE, Six Sigma or Lean Black Belt preferred.

Responsibilities

• Identify and optimize complex Manufacturing processes using SIX Sigma, LEAN methods for design for manufacturing and continuous process improvement.

Skills

CQE

Six Sigma

Lean Black Belt

Quality Engineering

Documentation

Cross-functional teamwork

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering or related field

Ph.D. in Engineering or related field

Tools

MS Office Suite

Job description

Planet Pharma in Irvine, CA is seeking a Pilot Operations Senior Quality Engineer to partner on validation activities for an introducer sheath used in THV devices. This role applies IQ/OQ/PQ knowledge and quality engineering methods to ensure regulatory compliance and reliable device delivery to patients.

Responsibilities include creating validation strategies, reviewing PFMEAs, developing training materials for production, and coordinating technicians.