Role SummaryThe Senior Manufacturing Engineer leads enterprise manufacturing operations support, validation strategy, implementation of manufacturing processes, documentation generation, process optimization, and cross-functional technical execution. The role is expected to operate with a high degree of independence, provide technical leadership to project teams, and mentor junior engineers or technical team members as needed.
Key Responsibilities- Lead IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
- Design and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for components and manufacturing processes.
- Generate, review, and approve equipment documentation, PM/calibration procedures, manufacturing instructions, and process control documentation.
- Manage enterprise manufacturing projects from concept through implementation; lead cross-functional technical collaboration with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and external suppliers as applicable.
- Apply DOE, PFMEA, risk analysis, SPC, MSA, and root-cause methodologies to characterize, optimize, and improve manufacturing processes.
- Lead Lean Manufacturing and continuous improvement initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance.
- Provide technical direction for manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification.
- Support change control, CAPA, nonconformance investigations, and product/process scale-up activities while maintaining compliance with site quality procedures.
Experience Requirements- Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field.
- 5-7+ years in manufacturing engineering, process engineering, validation engineering, or quality engineering within an FDA-regulated environment.
- Strong working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments.
- Electrical and mechanical engineering background applied to automated or semi-automated manufacturing systems.
- Experience with automation/controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation.
- Proficiency in DOE, FMEA/PFMEA, CAPA, root-cause investigation, statistical analysis, and process capability tools; experience with Minitab, JMP, or equivalent preferred.
- Experience with Lean Manufacturing, Six Sigma, Kaizen, value stream mapping, or other continuous improvement methodologies preferred.
- Experience supporting product introductions, process scale-up, design transfer, and improvements to existing manufacturing processes.
- Strong project management, communication, technical writing, analytical, and cross-functional leadership skills.
Quality Expectations- Demonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.
- Ensures proper documentation discipline and supports Quality System compliance while providing technical guidance to others as needed.
