Senior Manufacturing Process Engineer: Drive Validation

ResMed Inc; Calabasas (CA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Vision

Dental

Life insurance

AD&D

Disability insurance

HSA

401(k)

ESPP

EAP

Tuition assistance

Job summary

ResMed Inc. in Calabasas, CA is seeking a Senior / Manufacturing Process Engineer to improve process performance, lead validation activities, and drive continuous improvement across manufacturing systems.

You will own and optimize high‑volume production processes, collaborate with Quality, Product Development, Automation, and Operations, and deliver data‑driven improvements through SPC, DOE, and MES enhancements.

Qualifications

• Bachelor’s degree in engineering and at least 5 years of manufacturing/process engineering experience.
• Experience with ISO 13485, FDA regulations, and manufacturing validation.
• Hands-on experience with automated manufacturing equipment and systems.

Responsibilities

• Develop, optimize, and sustain manufacturing processes to improve quality, yield, throughput, and reliability.
• Lead validation activities and create IQ/OQ/PQ protocols and reports.
• Coordinate validation activities, project timelines, risks, and stakeholder communication.
• Support NPI, facility readiness, and automation deployment initiatives.
• Drive continuous improvement through CAPAs and data analytics.

Skills

Process engineering

Quality systems

Statistics

DOE

MSA/GR&R

CAPA

Project management

Cross-functional collaboration

Validation IQ/OQ/PQ

CAD SolidWorks

Data analysis (Minitab/JMP)

Flexible schedule

Education

Bachelor’s degree in Industrial/ Mechanical/ Manufacturing/ Biomedical Engineering

Master’s degree (preferred)

Tools

Power BI

Tableau

MES

eDHR

Job description

ResMed Inc. in Calabasas, CA is seeking a Senior / Manufacturing Process Engineer to improve process performance, lead validation activities, and drive continuous improvement across manufacturing systems.

You will own and optimize high‑volume production processes, collaborate with Quality, Product Development, Automation, and Operations, and deliver data‑driven improvements through SPC, DOE, and MES enhancements.