Note: The job is a remote job and is open to candidates in USA. Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. The Senior Manufacturing Engineer provides technical leadership for manufacturing operations by leading process validation, manufacturing process development, continuous improvement initiatives, and mentoring junior engineers.
Responsibilities
- Lead equipment and process validation activities (IQ/OQ/PQ), including validation strategy, protocol development, execution, and reporting
- Design and implement inspection methods, control plans, sampling plans, and manufacturing quality controls
- Develop, review, and maintain manufacturing documentation, including work instructions, equipment procedures, preventive maintenance, calibration, and process control documentation
- Manage manufacturing projects from concept through implementation while collaborating with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and external partners
- Apply engineering and quality tools such as DOE, PFMEA, SPC, MSA, risk analysis, and root cause investigations to optimize manufacturing processes
- Lead Lean Manufacturing and continuous improvement initiatives focused on productivity, quality, yield, throughput, process capability, and cost reduction
- Provide technical leadership for manufacturing technologies including automation, tooling, fixtures, vision systems, laser welding, heat bonding, injection molding, equipment qualification, and test methods
- Lead change controls, CAPA investigations, nonconformance investigations, process transfers, and product scale-up activities while ensuring regulatory compliance
- Mentor junior engineers and provide technical guidance to cross-functional teams
Skills
- Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or a related engineering discipline
- Five to seven or more years of experience in Manufacturing Engineering, Process Engineering, Validation Engineering, or Quality Engineering within a regulated manufacturing environment
- Strong knowledge of FDA Quality 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 quality tools including DOE, PFMEA, CAPA, SPC, MSA, root cause analysis, and statistical analysis
- Knowledge of Lean Manufacturing, Six Sigma, Kaizen, Value Stream Mapping, or other continuous improvement methodologies
- Experience supporting new product introductions, design transfer, process scale-up, and manufacturing process optimization
- Strong project management, leadership, communication, technical writing, analytical, and problem-solving skills
- Experience with Minitab, JMP, or similar statistical software
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