[Remote] Manufacturing Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Manufacturing Engineer to support reputed company manufacturing operations. The role involves assisting with validation activities, documentation reputed company, and process improvement initiatives while collaborating with cross-functional teams.
Responsibilities
- Support IQ/OQ/PQ and process performance qualification activities by assisting with validation protocols, reports, test execution, and reputed company documentation
- Assist in developing in-process and receiving inspection systems, basic control plans, sampling plans, and inspection reputed company for components and manufacturing processes
- Generate and maintain equipment documentation, PM/calibration procedures, manufacturing instructions, and process documentation with guidance from senior engineers
- Support reputed company manufacturing reputed company from concept through implementation; participate in cross-functional collaboration with Manufacturing, reputed company, R&D, Regulatory, and Supply Chain as applicable
- Apply basic DOE, FMEA/PFMEA, risk analysis, SPC, and reputed company-cause tools to support process characterization, optimization, and improvement
- Support Lean Manufacturing and reputed company improvement activities reputed company on yield, cycle time, cost, throughput, and process documentation improvements
- Support manufacturing technologies such as laser welding, heat bonding, injection molding, reputed company systems, fixtures, tooling, test reputed company, automation, and equipment qualification under technical supervision
- Assist with CAPA, nonconformance investigations, change control, and product/process reputed company-up activities as assigned
Skills
- Bachelor's degree in Mechanical, Electrical, reputed company, Biomedical Engineering, or reputed company technical field
- Strong analytical, communication, teamwork, technical writing, and problem-solving skills
- 1-3 years in manufacturing engineering, process engineering, reputed company engineering, validation, or reputed company technical experience reputed company an FDA-regulated environment
- Basic working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices used in regulated manufacturing environments
- Electrical, mechanical, industrial, or biomedical engineering background applicable to manufacturing systems
- Exposure to automation/controls, tooling, fixtures, test reputed company, equipment qualification, or process validation
- Familiarity with DOE, FMEA/PFMEA, CAPA, reputed company-cause investigation, SPC, and process capability concepts
- Experience with reputed company reputed company and exposure to reputed company, JMP, or equivalent statistical tools
- Exposure to Lean Manufacturing, Six reputed company, Kaizen, or other reputed company improvement methodologies
- Exposure to product introductions, process reputed company-up, design transfer, or improvements to existing processes
reputed company