Staff Engineer, Advanced Biologics Operations & NPI

Stryker Corporation; Franklin, Northern (NJ, KY); Hybrid; Confidential; Full time

Benefits offered by this job

Travel 20%

Job summary

Stryker Corporation in New Jersey is seeking a Staff Engineer, Advanced Operations to lead NPI and biologics process development. Hybrid or onsite in Mahwah, NJ, with collaboration across manufacturing and quality to ensure robust, compliant processes.

You will design, validate, and optimize upstream and downstream manufacturing, review documentation, and mentor engineers while coordinating with suppliers and cross‑functional teams.

Qualifications

• Bachelor's degree required in Mechanical Engineering or related field.
• 7+ years in manufacturing, process development, or related roles.
• Experience with regulated manufacturing environments.
• Experience with manufacturing process validation and documentation.

Responsibilities

• Lead development, optimization, and control of upstream and downstream biologics processes.
• Conduct process characterization and in-process control strategies.
• Evaluate and qualify manufacturing equipment and installation/validation.
• Generate PFMEAs, Control Plans, SOPs, and validation documents.
• Mentor engineers and provide technical updates to leadership.

Skills

Manufacturing processes

Process development

GD&T

MSA

DFM

Statistical analysis

Regulated manufacturing environments

Leadership / mentoring

Education

Bachelor's degree in Mechanical Engineering or related field

Job description

Stryker Corporation in New Jersey is seeking a Staff Engineer, Advanced Operations to lead NPI and biologics process development. Hybrid or onsite in Mahwah, NJ, with collaboration across manufacturing and quality to ensure robust, compliant processes.

You will design, validate, and optimize upstream and downstream manufacturing, review documentation, and mentor engineers while coordinating with suppliers and cross‑functional teams.