Role Summary
The 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
โขLead IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
โขDesign and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for components and manufacturing processes.
โขGenerate, review, and approve equipment documentation, PM/calibration procedures, manufacturing instructions, and process control documentation.
โขManage 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.
โขApply DOE, PFMEA, risk analysis, SPC, MSA, and root-cause methodologies to characterize, optimize, and improve manufacturing processes.
โขLead Lean Manufacturing and continuous improvement initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance.
โขProvide technical direction for manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification.
โขSupport change control, CAPA, nonconformance investigations, and product/process scale-up activities while maintaining compliance with site quality procedures.
Experience Requirements
โขBachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field.
โข5-7+ years in manufacturing engineering, process engineering, validation engineering, or quality engineering within an FDA-regulated environment.
โขStrong working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments.
โขElectrical and mechanical engineering background applied to automated or semi-automated manufacturing systems.
โขExperience with automation/controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation.
โขProficiency in DOE, FMEA/PFMEA, CAPA, root-cause investigation, statistical analysis, and process capability tools; experience with Minitab, JMP, or equivalent preferred.
โขExperience with Lean Manufacturing, Six Sigma, Kaizen, value stream mapping, or other continuous improvement methodologies preferred.
โขExperience supporting product introductions, process scale-up, design transfer, and improvements to existing manufacturing processes.
โขStrong 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.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*