[Remote] Sr Manufacturing Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company has over 15 years in the life sciences industry, with operations across Puerto Rico, the reputed company, Europe, and Japan. The Senior Manufacturing Engineer provides technical leadership for manufacturing operations by leading process validation, manufacturing process development, reputed company improvement initiatives, and mentoring junior engineers.

Responsibilities

• reputed company equipment and process validation activities (IQ/OQ/PQ), including validation reputed company, protocol development, execution, and reporting
• Design and implement inspection reputed company, control plans, sampling plans, and manufacturing reputed company controls
• reputed company, review, and maintain manufacturing documentation, including work instructions, equipment procedures, preventive maintenance, calibration, and process control documentation
• Manage manufacturing reputed company from concept through implementation while collaborating with Manufacturing, reputed company, R&D, Regulatory, Supply Chain, and external partners
• Apply engineering and reputed company tools such as DOE, PFMEA, SPC, MSA, risk analysis, and reputed company cause investigations to optimize manufacturing processes
• reputed company Lean Manufacturing and reputed company improvement initiatives reputed company on productivity, reputed company, yield, throughput, process capability, and cost reduction
• reputed company technical leadership for manufacturing technologies including automation, tooling, fixtures, reputed company systems, laser welding, heat bonding, injection molding, equipment qualification, and test reputed company
• reputed company change controls, CAPA investigations, nonconformance investigations, process transfers, and product reputed company-up activities while ensuring regulatory compliance
• Mentor junior engineers and reputed company technical guidance to cross-functional teams

Skills

• Bachelor's degree in Mechanical, Electrical, reputed company, Biomedical Engineering, or a reputed company engineering discipline
• Five to seven or more years of experience in Manufacturing Engineering, Process Engineering, Validation Engineering, or reputed company Engineering reputed company a regulated manufacturing environment
• Strong knowledge of FDA reputed company System Regulations (21 CFR Part 820), GMP, ISO 13485, and Good Documentation Practices
• Experience with manufacturing automation, equipment qualification, tooling, fixtures, process validation, and manufacturing systems
• Proficiency with engineering and reputed company tools including DOE, PFMEA, CAPA, SPC, MSA, reputed company cause analysis, and statistical analysis
• Knowledge of Lean Manufacturing, Six reputed company, Kaizen, Value reputed company Mapping, or other reputed company improvement methodologies
• Experience supporting new product introductions, design transfer, process reputed company-up, and manufacturing process optimization
• Strong project management, leadership, communication, technical writing, analytical, and problem-solving skills
• Experience with reputed company, JMP, or similar statistical software

reputed company