Staff Biologics Process Engineer – NPI & Manufacturing

Stryker; Mahwah (NJ); On-site; USD 89,000 - 179,000; Full time

Job summary

Stryker is seeking a Staff Engineer to support New Product Introduction and biologics process development in the United States. The role provides technical leadership across process design, validation, manufacturing readiness, and supplier collaboration to ensure compliant and robust biologics processes.

You will work with cross-functional teams to advance new product launches while focusing on process robustness, product quality, and operational excellence.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field is required.
• 7+ years of engineering experience in manufacturing, process development, product development, or related field.
• Experience supporting regulated manufacturing environments.
• Experience with design for manufacturing (DFM), process capability studies, and MSA.
• Experience interpreting engineering drawings, GD&T.

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 based on specs and regulations; support installation and validation activities.
• Generate and review documentation including PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, and studies for product launches.
• Mentor engineers and deliver technical updates to stakeholders and leadership.

Skills

Technical leadership

Process development

Manufacturing readiness

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering

Job description

Stryker is seeking a Staff Engineer to support New Product Introduction and biologics process development in the United States. The role provides technical leadership across process design, validation, manufacturing readiness, and supplier collaboration to ensure compliant and robust biologics processes.

You will work with cross-functional teams to advance new product launches while focusing on process robustness, product quality, and operational excellence.