Manufacturing Engineer
$100,000–$110,000 year
On-site · Camarillo, California, United States
Job Summary
Manufacturing Engineer at SaniSure focused on leading process engineering, continuous improvement, and NPI manufacturing readiness in a GMP medical device environment. Responsible for pFMEA/Control Plans, IQ/OQ/PQ validation, BOM support, RCCA/CAPAs/NCRs, SOPs/work instructions, process documentation, data-driven decision making (SPC/Cpk), and cross-functional collaboration with Operations, Quality, and R&D. Drives efficiency and regulatory compliance through Lean Six Sigma methodologies, process validation, design verification/validation support, cost and capacity analysis, and timely maintenance coordination. Travel up to 10% and contribute to audits and continuous improvement initiatives in a global manufacturing setting.
Required Qualifications
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or another related STEM field
- 5+ years of hands-on manufacturing engineering experience in a medical device, pharmaceutical, or regulated manufacturing environment
- Lean Six Sigma tools including Value Stream Mapping, SPC, Cpk, time studies, capacity modeling, and Kaizen; Green Belt or Black Belt certification preferred
- Experience authoring and executing IQ/OQ/PQ protocols, validation runs, and Gage R&R studies; familiarity with process qualification requirements in a GMP environment
- Solid understanding of pFMEA, Control Plans, and process risk management methodology; change control and documentation experience in a regulated quality system
- Proficient in structured root cause and corrective action methodologies (RCCA); experience authoring, tracking, and closing CAPAs and NCRs
- Ability to read and interpret 2D and 3D engineering drawings, blueprints, and CAD models in support of process design and tooling assessments
- Experience developing and maintaining SOPs, work instructions, process flow diagrams, and other GMP-compliant manufacturing documentation
- Self-starter with strong project management skills; able to manage multiple priorities independently with minimal supervision
- Strong verbal and written communication skills; ability to effectively interact with personnel at all levels and present data-driven findings to management
- Experience working in a GMP manufacturing or regulated laboratory environment; familiarity with applicable FDA, ISO 13485, and other relevant regulatory standards
- Able to travel up to 10%
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