Senior Staff Engineer – Advanced Operations

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 plays a key role in bringing new products into manufacturing. As a Senior Staff Engineer, you will provide process engineering leadership during design transfer, equipment implementation, and process development activities, partnering across engineering, quality, manufacturing, and regulatory teams to support successful product launches in a regulated environment.

What You Will Do

• Lead process engineering activities for new product introductions, ensuring manufacturing readiness and compliance with design transfer requirements.
• Develop and implement manufacturing processes, methods, and controls that meet product quality, cost, and schedule objectives.
• Create and support process risk assessments, control plans, manufacturing procedures, and production validation activities for new product launches.
• Evaluate, select, procure, install, and validate manufacturing equipment and capital assets to support production requirements.
• Analyze process and equipment performance through testing, data collection, measurement system analysis, and experimental studies to optimize manufacturing outcomes.
• Develop inspection methods, test protocols, and manufacturing controls to ensure products meet defined specifications and regulatory requirements.
• Provide technical guidance on manufacturing standards, design requirements, testing strategies, and regulatory expectations while mentoring engineers and project teams.
• Partner with Research & Development, Quality, Manufacturing, Regulatory Affairs, Marketing, and Project Management teams to resolve technical challenges and achieve project milestones.

What You Will Need

Required Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• Minimum 6 years of experience in process engineering, manufacturing engineering, advanced operations, or a related technical field.
• Experience interpreting system drawings involving mechanical, electrical, and software interactions.

Preferred Qualifications

• Experience in an FDA-regulated industry or other highly regulated manufacturing environment.
• Experience reading and interpreting engineering drawings, including geometric dimensioning and tolerancing (GD&T).
• Certification(s) in Project Management, LEAN, Six Sigma, Operational Excellence, and/or related.

$102,600 - $171,000 USD Annual