Senior Manufacturing Process Engineer (Onsite)

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. This role serves as the technical owner of manufacturing processes within the Motors PFT, ensuring processes are capable, compliant, scalable, and data driven. 

The position collaborates closely with Operations, Quality, Product Development, Automation, Test Engineering, Planning, and Facilities to support production, process transfers, validation, and continuous improvement initiatives. 

What You'll Do

Process Optimization 

• 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. 

• Reduce scrap, rework, downtime, and process variation. 

• Establish process controls, reaction plans, control plans, and standard work. 

• Support production troubleshooting and technical issue resolution. 

Project Management 

• Lead manufacturing engineering projects from concept through implementation. 

• Manage engineering trials, equipment upgrades, and process changes. 

• Coordinate validation activities, project timelines, deliverables, risks, and stakeholder communication. 

• Support NPI, facility readiness, and automation deployment initiatives. 

• Drive closure of engineering action items, CAPAs, and continuous improvement projects. 

Regulatory Compliance and Documentation 

• Author and execute Process Validation Plans, IQ/OQ/PQ protocols, and validation reports. 

• Maintain PFMEAs, control plans, process flow diagrams, and Requirements Traceability Matrices. 

• Support Process Change Assessments, risk assessments, and revalidation activities. 

• Ensure manufacturing processes comply with QMS, regulatory, and audit requirements. 

• Maintain accurate, audit-ready technical documentation and engineering records. 

Collaboration and Cross-Functional Support 

• Partner with Production, Quality, Product Development, Test Engineering, Automation, Maintenance, Planning, and Facilities teams. 

• Represent Manufacturing Engineering during design reviews, project reviews, validation reviews, and audits. 

• Provide technical guidance and training to operators, technicians, and engineering teams. 

• Support issue resolution across product lifecycle stages from development through production. 

• Facilitate effective communication between manufacturing operations and development teams. 

Innovation and Continuous Improvement 

• Develop and maintain manufacturing dashboards, analytics, and process-monitoring tools. 

• Leverage manufacturing data to identify trends, opportunities, and performance gaps. 

• Drive automation, digitization, and manufacturing systems improvements (MES, eDHR, Power BI, Tableau, etc.). 

• Evaluate and implement new technologies, tools, and best practices. 

• Lead continuous improvement initiatives focused on safety, quality, productivity, and cost reduction. 

What You Bring

Minimum Qualifications 

• 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. 

• Proven track record of leading and supporting engineering projects in highly collaborative, cross-functional environments. 

• 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. 

• Knowledge of manufacturing processes & equipment for high volume production of discrete products. 

• Excellent communication and documentation skills, including technical reports. 

• Proficient with CAD software (e.g., SolidWorks) and data analysis/statistical tools (e.g., Minitab, JMP). 

• Ability and willingness to work a flexible schedule to support project execution, validation activities, and critical production issues. 

• Perform other duties as assigned to support business, operational, and project objectives. 

Preferred Qualifications 

• Master's degree in an engineering-related field. 

• Experience in medical device manufacturing and regulated environments. 

• Knowledge of manufacturing systems, process monitoring systems, and statistical process control. 

• Six Sigma Green Belt or higher certification. 

• Experience with manufacturing data analytics platforms such as Power BI, Tableau, MES, or eDHR systems. 

• Experience supporting automation, equipment commissioning, line transfers, or new product introduction (NPI). 

What Sets You Apart

Core Competencies 

• Strong analytical problem-solving and decision-making skills. 

• Excellent communication and interpersonal abilities. 

• Detail-oriented with a strong commitment to quality, compliance, and documentation. 

• Ability to manage multiple priorities in a fast-paced manufacturing environment. 

• Strong project management and organizational skills. 

• Team player with a proactive approach to innovation and continuous improvement. 

• Ability to influence and collaborate effectively across Operations, Quality, Product Development, Planning, Automation, and Facilities teams. 

Why Join ResMed