Staff Engineer, Biologics Process Development & Manufacturing

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

Job summary

Stryker Group in Mahwah, NJ seeks a Staff Engineer to lead NPI and biologics process development, ensuring robust, compliant processes across design, validation, and manufacturing readiness. You will drive cross-functional collaboration with internal teams and suppliers to enable successful product launches while maintaining quality and regulatory compliance.

The role emphasizes process optimization, documentation, and mentorship of engineers, with a strong focus on design for manufacturability

Qualifications

• Must have manufacturing process development experience.
• Experience with validation methodologies.
• Familiarity with GD&T and specifications.

Responsibilities

• Lead 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 studies to establish process robustness.
• Evaluate, select, and qualify manufacturing equipment and components; support installation and validation activities.
• Generate and review technical documentation (PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, MSA, etc.).
• Mentor engineers and provide technical guidance across product portfolios and stakeholders.

Skills

Process design

Validation

Supplier collaboration

Cross-functional leadership

Education

Bachelor’s degree in Mechanical Engineering

Job description

Stryker Group in Mahwah, NJ seeks a Staff Engineer to lead NPI and biologics process development, ensuring robust, compliant processes across design, validation, and manufacturing readiness. You will drive cross-functional collaboration with internal teams and suppliers to enable successful product launches while maintaining quality and regulatory compliance.

The role emphasizes process optimization, documentation, and mentorship of engineers, with a strong focus on design for manufacturability