Senior Manufacturing Process Engineer (Onsite)
Salary$120k – $180k
LocationCalabasas, CA, United States
Work modeon-site
Typefull-time
SenioritySenior
Experience5+ yrs
EquityIncluded
Company size10,000+ people
PostedSep 16, 2026 · 3w ago
Verified live17h ago
At a glanceSummarised by Seekless from the posting.
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
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)
Skills
CAD
SolidWorks
Minitab
JMP
Power BI
Tableau
MES
eDHR
ISO 13485
Benefits
Health insurance
Dental insurance
Vision insurance
Life insurance
Ad&d
Short term disability
Long term disability
Sleep care management
HSA
FSA
Commuter benefits
401(k)
ESPP
EAP
Tuition assistance
Unlimited PTO
Paid holidays
Primary caregiver leave
Secondary caregiver leave
About the role
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
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Develop, optimize, and sustain manufacturing processes to improve quality, yield, throughput, and reliability.
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Conduct process capability studies, SPC analysis, MSA/GR&R, DOE, and root cause investigations.
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Reduce scrap, rework, downtime, and process variation.
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Establish process controls, reaction plans, control plans, and standard work.
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Support production troubleshooting and technical issue resolution.
Project Management
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Lead manufacturing engineering projects from concept through implementation.
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Manage engineering trials, equipment upgrades, and process changes.
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Coordinate validation activities, project timelines, deliverables, risks, and stakeholder communication.
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Support NPI, facility readiness, and automation deployment initiatives.
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Drive closure of engineering action items, CAPAs, and continuous improvement projects.
Regulatory Compliance and Documentation
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Author and execute Process Validation Plans, IQ/OQ/PQ protocols, and validation reports.
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Maintain PFMEAs, control plans, process flow diagrams, and Requirements Traceability Matrices.
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Support Process Change Assessments, risk assessments, and revalidation activities.
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Ensure manufacturing processes comply with QMS, regulatory, and audit requirements.
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Maintain accurate, audit-ready technical documentation and engineering records.
Collaboration and Cross-Functional Support
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Partner with Production, Quality, Product Development, Test Engineering, Automation, Maintenance, Planning, and Facilities teams.
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Represent Manufacturing Engineering during design reviews, project reviews, validation reviews, and audits.
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Provide technical guidance and training to operators, technicians, and engineering teams.
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Support issue resolution across product lifecycle stages from development through production.
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Facilitate effective communication between manufacturing operations and development teams.
Innovation and Continuous Improvement
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Develop and maintain manufacturing dashboards, analytics, and process-monitoring tools.
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Leverage manufacturing data to identify trends, opportunities, and performance gaps.
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Drive automation, digitization, and manufacturing systems improvements (MES, eDHR, Power BI, Tableau, etc.).
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Evaluate and implement new technologies, tools, and best practices.
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Lead continuous improvement initiatives focused on safety, quality, productivity, and cost reduction.
What You Bring
Minimum Qualifications
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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
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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
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Strong analytical problem-solving and decision-making skills.
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Excellent communication and interpersonal abilities.
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Detail-oriented with a strong commitment to quality, compliance, and documentation.
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Ability to manage multiple priorities in a fast-paced manufacturing environment.
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Strong project management and organizational skills.
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Team player with a proactive approach to innovation and continuous improvement.
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Ability to influence and collaborate effectively across Operations, Quality, Product Development, Planning, Automation, and Facilities teams.
Why Join 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. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. Employees accrue three weeks Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.
Legal
Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.
At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range for this position is: $120,000 to $180,000
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.