Senior Biologics Process Engineer - NPI & Manufacturing

Stryker; Arlington (TN); On-site; USD 89,000 - 179,000; Full time

Job summary

Stryker is seeking a Staff Engineer to lead NPI and biologics process development, providing technical leadership across design, validation, manufacturing readiness, and supplier collaboration to ensure compliant processes.

You will work with cross-functional teams to advance new product launches, emphasizing process robustness, product quality, and operational excellence. The role requires a Bachelor's degree and 7+ years in regulated manufacturing environments.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related engineering discipline.
• 7+ years of engineering experience in manufacturing, process development, or product development.
• 7+ years of experience supporting regulated manufacturing environments.
• Experience interpreting engineering drawings, GD&T, and measurement techniques.

Responsibilities

• Lead the development, optimization, and control of upstream and downstream biologics manufacturing processes across internal and supplier operations.
• Conduct process characterization, variability, hold-time, and worst-case condition studies to establish process robustness and define in-process control strategies.
• Evaluate, select, and qualify manufacturing equipment and components based on technical specifications, reliability requirements, and applicable regulations; support equipment installation and validation activities.
• Generate and review technical documentation including PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, MSA studies, and inspection documentation to support product launches.
• Mentor engineers, provide technical guidance across multiple product portfolios, and deliver technical updates and recommendations to stakeholders and leadership.

Skills

Process development

Manufacturing readiness

Leadership

Education

B.S. in Mechanical Eng

Tools

GD&T

MSA

DFM

Statistical analysis

Job description

Stryker is seeking a Staff Engineer to lead NPI and biologics process development, providing technical leadership across design, validation, manufacturing readiness, and supplier collaboration to ensure compliant processes.

You will work with cross-functional teams to advance new product launches, emphasizing process robustness, product quality, and operational excellence. The role requires a Bachelor's degree and 7+ years in regulated manufacturing environments.