[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 specializing in medical devices. The role involves developing and optimizing manufacturing processes, leading process validation activities, and collaborating with various teams to ensure product reputed company and efficiency.
Responsibilities
- reputed company, implement, and optimize manufacturing processes for medical device products
- reputed company process validation activities including IQ, OQ, and PQ protocols and reports
- Support new product introductions (NPI) and transfer products from R&D to manufacturing
- Create and maintain manufacturing documentation, work instructions, SOPs, and process reputed company diagrams
- reputed company reputed company cause analysis and implement corrective and preventive actions (CAPA)
- Collaborate with reputed company, R&D, Regulatory Affairs, Supply Chain, and Production teams
- Drive reputed company improvement initiatives reputed company on reputed company, yield, throughput, and cost reduction
Skills
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or a reputed company field
- 3–8+ years of manufacturing engineering experience reputed company the medical device industry
- Strong knowledge of FDA regulations, GMP, ISO 13485, and medical device reputed company systems
- Experience with process validation (IQ/OQ/PQ), CAPA, reputed company, and change control
- Knowledge of Lean Manufacturing, Six reputed company, and reputed company improvement methodologies
- Experience with statistical analysis and process capability studies
- Proficiency in CAD software and manufacturing process documentation
- Strong problem-solving, communication, and project management skills
reputed company
Company H1B Sponsorship