Staff Manufacturing Engineer

Stryker; Waltham (MA); Híbrido; USD 107.000 - 179.000; Jornada completa

Descripción de la vacante

Stryker Group in Waltham, MA, seeks a Senior Manufacturing Engineer to drive process improvements and support introductions of new and existing products into production.

You will lead cross-functional projects, apply GMP and Six Sigma methodologies, and optimize throughput while ensuring product quality and safety across manufacturing lines.

Formación

• Bachelor's degree in Engineering required; Mechanical, Electrical, Biomedical, Manufacturing, or Industrial preferred.
• Minimum 4 years of engineering experience in manufacturing, process engineering, or related technical environment.
• Preferred: Lean Manufacturing, Six Sigma, or GMP experience in production environments.
• Preferred: experience with Engineering Change Orders (ECOs) and change-management in regulated industries.

Responsabilidades

• Lead manufacturing engineering projects, track milestones, communicate project status, and drive timely resolution of technical and operational issues.
• Support and improve manufacturing processes using statistical methods, Lean Manufacturing, Six Sigma, and GMP principles.
• Transfer new products, design changes, and product line extensions into production through structured validation and implementation activities.
• Troubleshoot manufacturing, tooling, fixture, and equipment issues to identify root causes and implement sustainable corrective actions.
• Design, procure, install, and qualify production fixtures, equipment, and tools through IQ/OQ/PQ protocols to improve efficiency, safety, and product quality.
• Conduct failure analyses and implement design or process improvements to enhance product functionality, performance, and manufacturability.
• Identify and execute process improvement initiatives that reduce scrap, improve yield, increase throughput, and optimize production line performance.
• Develop technical protocols, reports, standard operating procedures, visual work instructions, and training programs; deliver training for new product launches and process changes.

Conocimientos

Lean Manufacturing

Six Sigma

GMP compliance

Project management

Educación

Bachelor's degree in Engineering

Herramientas

ECOs

Change management

Descripción del empleo

The Senior Manufacturing Engineer partners across functions to drive process improvements, resolve technical challenges, and support the successful introduction of new and existing products into production.

What You Will Do

• Lead manufacturing engineering projects, track milestones, communicate project status, and drive timely resolution of technical and operational issues.


• Support and improve manufacturing processes using statistical methods, Lean Manufacturing, Six Sigma, and Good Manufacturing Practice (GMP) principles.


• Transfer new products, design changes, and product line extensions into production through structured validation and implementation activities.


• Troubleshoot manufacturing, tooling, fixture, and equipment issues to identify root causes and implement sustainable corrective actions.


• Design, procure, install, and qualify production fixtures, equipment, and tools through IQ/OQ/PQ protocols to improve efficiency, safety, and product quality.


• Conduct failure analyses and implement design or process improvements to enhance product functionality, performance, and manufacturability.


• Identify and execute process improvement initiatives that reduce scrap, improve yield, increase throughput, and optimize production line performance.


• Develop technical protocols, reports, standard operating procedures, visual work instructions, and training programs; deliver training for new product launches and process changes.

What You Will Need

Required Qualifications

• Bachelor's degree in Engineering; Mechanical, Electrical, Biomedical, Manufacturing, or Industrial Engineering preferred.


• Minimum 4 years of engineering experience in manufacturing, process engineering, or a related technical environment.

Preferred Qualifications

• Certification and/or experience applying Lean Manufacturing, Six Sigma, or continuous improvement methodologies in a production environment.


• Experience with Engineering Change Orders (ECOs), change justification documentation, and assembly procedure change management.


• Experience in a highly regulated manufacturing environment, such as medical device, pharmaceutical, or other regulated industries.


• Experience planning and managing engineering projects using project management tools and methodologies (e.g., Gantt charts, PERT charts).

$107,200 - $178,600 USD Annual