Staff Engineer, Advanced Operations (Biologics NPI)

About the role

Stryker is hiring a Staff Engineer in Advanced Operations to support New Product Introduction (NPI) and biologics process development. The role provides technical leadership across process design, validation, manufacturing readiness and supplier collaboration so that biologics processes are developed, controlled and documented in compliance with quality and regulatory requirements. Work is hybrid or onsite, with 20% travel.

Key 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, and support equipment installation and validation.
• Generate and review technical documentation such as PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, MSA studies and inspection documentation.
• Mentor engineers, give technical guidance across product portfolios and share updates and recommendations with stakeholders and leadership.

Required profile

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• Minimum 4 years of engineering experience in manufacturing, process development, product development or a related field.
• Minimum 4 years of experience supporting regulated manufacturing environments.
• Experience developing and validating manufacturing processes, including statistical analysis and verification/validation methodologies.
• Experience interpreting engineering drawings, specifications and GD&T.
• Preferred: 7 years in regulated manufacturing, biologics manufacturing or process development, and experience in FDA-regulated or ISO 13485-regulated industries with complex global supply chains.

Required skills

• Design for Manufacturing (DFM)
• Process capability studies
• Measurement system analysis (MSA)

What we offer

• Pay range of $89,300 to $148,800 USD annually (USN) or $107,200 to $178,600 USD annually (US20).
• Hybrid or onsite work arrangement.