Currently looking for two (2) Manufacturing Engineers at Jr. Level (1-3 yrs) and Sr. Level (5-7 years).
Manufacturing Engineer (Jr. Level)
Role Summary
The Manufacturing Engineer supports enterprise manufacturing operations by assisting with validation activities, documentation generation, manufacturing instructions, data analysis, and process improvement initiatives under the guidance of senior engineering and cross-functional team members.
Key Responsibilities
· Support IQ/OQ/PQ and process performance qualification activities by assisting with validation protocols, reports, test execution, and related documentation.
· Assist in developing in-process and receiving inspection systems, basic control plans, sampling plans, and inspection methods for components and manufacturing processes.
· Generate and maintain equipment documentation, PM/calibration procedures, manufacturing instructions, and process documentation with guidance from senior engineers.
· Support enterprise manufacturing projects from concept through implementation; participate in cross-functional collaboration with Manufacturing, Quality, R&D, Regulatory, and Supply Chain as applicable.
· Apply basic DOE, FMEA/PFMEA, risk analysis, SPC, and root-cause tools to support process characterization, optimization, and improvement.
· Support Lean Manufacturing and continuous improvement activities focused on yield, cycle time, cost, throughput, and process documentation improvements.
· Support manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification under technical supervision.
· Assist with CAPA, nonconformance investigations, change control, and product/process scale-up activities as assigned.
Experience Requirements
· Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field.
· 1-3 years in manufacturing engineering, process engineering, quality engineering, validation, or related technical experience within an FDA-regulated environment preferred.
· Basic working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices used in regulated manufacturing environments preferred.
· Electrical, mechanical, industrial, or biomedical engineering background applicable to manufacturing systems.
· Exposure to automation/controls, tooling, fixtures, test methods, equipment qualification, or process validation preferred.
· Familiarity with DOE, FMEA/PFMEA, CAPA, root-cause investigation, SPC, and process capability concepts.
· Experience with Microsoft Excel and exposure to Minitab, JMP, or equivalent statistical tools preferred.
· Exposure to Lean Manufacturing, Six Sigma, Kaizen, or other continuous improvement methodologies preferred.
· Exposure to product introductions, process scale-up, design transfer, or improvements to existing processes preferred.
· Strong analytical, communication, teamwork, technical writing, and problem-solving 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 with guidance from senior engineers and quality partners.
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Sr. Manufacturing Engineer (Sr. Level)
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
· 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.
Work Location: In person
