Staff Engineer, Biologics NPI & Process Leadership

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker is seeking a Staff Engineer to lead New Product Introduction and biologics process development. You will provide technical leadership across process design, validation, manufacturing readiness, and supplier collaboration to ensure compliant, robust processes for launches.

You will mentor engineers, review documentation, and work with cross-functional teams to drive quality and operational excellence as you advance new products from concept to production.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 7+ years in manufacturing, process or product development.
• 7+ years in regulated manufacturing environments.
• Experience developing and validating manufacturing processes; statistics.
• GD&T interpretation experience.
• DFM, process capability studies, and MSA experience.

Responsibilities

• Lead development, optimization, and control of biologics manufacturing processes across internal and supplier operations.
• Conduct process characterization, variability, hold-time, and worst-case studies to define in-process control strategies.
• Evaluate, select, and qualify manufacturing equipment; support installation and validation activities.
• Generate and review PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, MSA studies, and inspection documentation.
• Mentor engineers, provide technical guidance across multiple product portfolios, and deliver updates to stakeholders and leadership.

Skills

Manufacturing process development

Statistical analysis

Process validation

GD&T interpretation

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering or related field

Tools

PFMEA

Control Plans

MSA

Process capability studies

Job description

Stryker is seeking a Staff Engineer to lead New Product Introduction and biologics process development. You will provide technical leadership across process design, validation, manufacturing readiness, and supplier collaboration to ensure compliant, robust processes for launches.

You will mentor engineers, review documentation, and work with cross-functional teams to drive quality and operational excellence as you advance new products from concept to production.