Staff Engineer, Biologics NPI & Process Excellence

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

Benefits offered by this job

Health benefits including medical and

Dental insurance

Vision insurance

Critical illness insurance

Accident insurance

Hospital indemnity insurance

Wellbeing program

Tobacco cessation program

HSA and FSAs

401(k) plan

Employee Stock Purchase Plan (ESPP)

Basic life and AD&D insurance

Short-term disability

Job summary

Stryker is seeking a Staff Engineer to support New Product Introduction (NPI) and biologics process development. You will provide technical leadership across design, validation, and manufacturing readiness, while collaborating with suppliers to ensure compliant, robust biologics processes that meet quality and regulatory requirements.

You will mentor engineers, drive process optimization, and deliver updates to stakeholders to enable successful product launches with a focus on robustness and

Qualifications

• Bachelor’s degree in Mechanical Engineering or a related field.
• Minimum 7 years of engineering experience in manufacturing, process development, product development, or a related field.
• Minimum 7 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.
• Experience with Design for Manufacturing (DFM), process capability studies, and measurement system analysis (MSA).

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 based on technical specifications, reliability requirements, and applicable regulations; support equipment installation and validation activities.
• Generate and review technical documentation including PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, MSA studies, and inspection documentation to support product launches.
• Mentor engineers, provide technical guidance across multiple product portfolios, and deliver technical updates and recommendations to stakeholders and leadership.

Skills

Technical leadership

Process development

Biologics manufacturing

Cross-functional collaboration

Documentation

Education

Bachelor’s degree in Mechanical Engineering

Job description

Stryker is seeking a Staff Engineer to support New Product Introduction (NPI) and biologics process development. You will provide technical leadership across design, validation, and manufacturing readiness, while collaborating with suppliers to ensure compliant, robust biologics processes that meet quality and regulatory requirements.

You will mentor engineers, drive process optimization, and deliver updates to stakeholders to enable successful product launches with a focus on robustness and