Staff Engineer, Advanced Operations

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

Join Stryker as a Staff Engineer supporting New Product Introduction (NPI) and biologics process development. This role provides technical leadership across process design, validation, manufacturing readiness, and supplier collaboration to ensure biologics processes are developed, controlled, and documented in compliance with applicable quality and regulatory requirements. You will work across cross-functional teams to advance new product launches while maintaining a strong focus on process robustness, product quality, and operational excellence.

What You Will Do

• 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.

What You Will Need

Required:

• Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
• 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 geometric dimensioning and tolerancing (GD&T).
• Experience with Design for Manufacturing (DFM), process capability studies, and measurement system analysis (MSA).

Preferred:

• Experience supporting biologics manufacturing or biologics process development.
• Experience in FDA-regulated or ISO 13485-regulated industries and supporting complex global supply chains.

United States of America Pay Ranges:

• USN: $89,300 - $148,800 USD Annual
• US20: $107,200 - $178,600 USD Annual

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