Resmed
Senior / Manufacturing Process Engineer
Overview
The Senior / Manufacturing Process Engineer is responsible for improving manufacturing process performance, leading validation activities, and leveraging manufacturing systems and data to drive operational excellence.
About Resmed
We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent.
Requirements & Eligibility
- Senior Process Engineer: Minimum 5 years of manufacturing/process engineering experience.
- Bachelor's degree in Industrial Engineering, Mechanical Engineering, Manufacturing Systems Engineering, Biomedical Engineering, or a related engineering discipline.
- Experience supporting production lines in a 24/7 manufacturing environment.
- Hands-on experience with automated manufacturing equipment and systems.
- Strong knowledge of quality systems, including ISO 13485, FDA regulations, and manufacturing validation practices.
- Experience with process validation, including IQ/OQ/PQ, risk assessments, and change management.
Key Responsibilities
- Develop, optimize, and sustain manufacturing processes to improve quality, yield, throughput, and reliability.
- Conduct process capability studies, SPC analysis, MSA/GR&R, DOE, and root cause investigations.
- Lead manufacturing engineering projects from concept through implementation.
- Author and execute Process Validation Plans, IQ/OQ/PQ protocols, and validation reports.
- Partner with Production, Quality, Product Development, Test Engineering, Automation, Maintenance, Planning, and Facilities teams.
- Drive automation, digitization, and manufacturing systems improvements (MES, eDHR, Power BI, Tableau, etc.).
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