Senior Manufacturing Engineer - Remote/Hybrid

Stryker; Florida; On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker Corporation in Florida is seeking a Manufacturing Engineer to support production operations by troubleshooting process issues and leading root cause investigations. You will execute IQ/OQ/PQ and validate processes in a regulated setting, analyze data with statistical tools, and drive improvements in quality, throughput, ergonomics, and cost.

Collaborate with Quality, R&D, Advanced Operations, and Supply Chain teams to enable design for manufacturability and new product introductions,

Qualifications

• Bachelor's degree in a related engineering discipline is required.
• Minimum 2 years of manufacturing engineering experience.
• Experience supporting complex mechanical and/or electromechanical assemblies.
• Experience working within a regulated manufacturing environment.
• Experience supporting nonconformance investigations, corrective and preventive actions, process validation, and continuous improvement initiatives.
• Knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and risk-based validation methodologies.
• Proficiency with engineering and statistical analysis tools such as SolidWorks, Minitab, and Geometric Dimensioning & Tolerancing (GD&T).

Responsibilities

• Provide direct manufacturing engineering support to production operations by troubleshooting process issues and leading root cause investigations.
• Execute manufacturing process validation and equipment qualification activities (IQ, OQ, PQ) in compliance with quality and regulatory requirements.
• Analyze manufacturing data using statistical tools to improve process capability and identify opportunities to improve quality and throughput.
• Collaborate with Quality, R&D, Advanced Operations, and Supply Chain to support DFx, NPI, production readiness, and continuous improvement.
• Develop and maintain manufacturing documentation including work instructions, SOPs, FMEAs, control plans, and visual aids.

Skills

Root cause analysis

FDA QSR knowledge

GD&T

Minitab

SolidWorks

Statistical analysis

Process validation

Manufacturing engineering

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Industrial Engineering

Bachelor's degree in Biomedical Engineering

Tools

Geometric Dimensioning & Tolerancing (GD&T)

Job description

Stryker Corporation in Florida is seeking a Manufacturing Engineer to support production operations by troubleshooting process issues and leading root cause investigations. You will execute IQ/OQ/PQ and validate processes in a regulated setting, analyze data with statistical tools, and drive improvements in quality, throughput, ergonomics, and cost.

Collaborate with Quality, R&D, Advanced Operations, and Supply Chain teams to enable design for manufacturability and new product introductions,