Employment type: Full time and onsite roleRole SummaryThe Senior Manufacturing Engineer provides technical leadership for manufacturing operations by leading process validation, manufacturing process development, continuous improvement initiatives, and cross-functional engineering projects. This role works independently, drives technical solutions, and mentors junior engineers while ensuring compliance with quality and regulatory requirements.
Key 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.
Requirements- 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.
- Experience with Minitab, JMP, or similar statistical software is preferred.
- 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.
Quality Expectations- Ensure compliance with all applicable quality procedures, regulatory requirements, and documentation standards.
- Promote a culture of product quality, patient safety, and continuous improvement while providing technical leadership across engineering and manufacturing teams.
