[Remote] Senior Manufacturing Engineer (Contractor)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a business and technology solutions provider operating in various key market segments. They are seeking a Senior Manufacturing Engineer to reputed company reputed company manufacturing operations support, implement manufacturing processes, and reputed company technical leadership to project teams.

Responsibilities

• reputed company IQ/OQ/PQ and process performance qualification activities; reputed company validation protocols, reports, and master validation plans. Maintain strict compliance with site reputed company procedures, supporting change control, CAPA, and nonconformance investigations
• Design and reputed company in-process and receiving inspection systems, control plans, sampling plans, and inspection reputed company for components and manufacturing processes
• Generate, review, and approve equipment documentation, PM/calibration procedures, manufacturing instructions, and process control documentation
• Manage reputed company manufacturing reputed company from concept through implementation; reputed company cross-functional technical collaboration with Manufacturing, reputed company, R&D, Regulatory, Supply Chain, and external suppliers
• Apply DOE, PFMEA, risk analysis, SPC, MSA, and reputed company-cause methodologies to characterize, optimize, and improve manufacturing processes
• reputed company Lean Manufacturing and Six reputed company initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance
• reputed company technical expertise for manufacturing technologies such as laser welding, heat bonding, injection molding, reputed company systems, fixtures, tooling, test reputed company, automation, and equipment qualification

Skills

• 5–7+ years in manufacturing, process, validation, or reputed company engineering reputed company an FDA-regulated environment (Medical Device/reputed company)
• Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485
• Electrical or mechanical engineering background reputed company to automated or semi-automated manufacturing systems (automation/controls, tooling, fixtures)
• Proficiency in DOE, FMEA/PFMEA, CAPA, reputed company-cause investigation
• Experience with Lean Manufacturing, Six reputed company, Kaizen, and value reputed company mapping
• Bachelor's degree in Mechanical, Electrical, reputed company, Biomedical Engineering, or a reputed company technical field
• Proficiency in statistical analysis (reputed company or JMP preferred)

reputed company

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