Senior Process Engineer — Medical Devices Launch Lead

Stryker Group; Portage (MI); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker Medical’s Advanced Operations team seeks a Senior Staff Engineer to lead process engineering during design transfer, equipment implementation, and process development for regulated products. You will partner with across engineering, quality, manufacturing, and regulatory teams to enable successful product launches.

The role requires a Bachelor’s degree and 6+ years of process/manufacturing engineering experience in a regulated environment, with proficiency in interpreting GD&T and system

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 6+ years in process/manufacturing engineering or related field.
• Experience interpreting drawings with mechanical/electrical/software interactions.

Responsibilities

• Lead process engineering activities for new product introductions and manufacturing readiness.
• Develop and implement manufacturing processes, methods, and controls.
• Create and support process risk assessments and control plans.
• Evaluate equipment selection, installation, and validation.
• Analyze process performance via testing and data collection.
• Develop inspection methods and manufacturing controls to meet specs.
• Provide technical guidance on standards, testing, and regulatory expectations.
• Collaborate with R&D, Quality, Manufacturing, Regulatory, Marketing, and PM teams.

Skills

Manufacturing engineering experience

Regulatory compliance understanding

GD&T reading

Data collection & analysis

Risk assessment & control plans

Education

Bachelor's Degree in Engineering

Tools

GD&T

Measurement system analysis

Job description

Stryker Medical’s Advanced Operations team seeks a Senior Staff Engineer to lead process engineering during design transfer, equipment implementation, and process development for regulated products. You will partner with across engineering, quality, manufacturing, and regulatory teams to enable successful product launches.

The role requires a Bachelor’s degree and 6+ years of process/manufacturing engineering experience in a regulated environment, with proficiency in interpreting GD&T and system