Staff Engineer, Advanced Operations

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

Job summary

Stryker is seeking a Staff Engineer to support New Product Introduction and biologics process development in the United States. The role provides technical leadership across process design, validation, manufacturing readiness, and supplier collaboration to ensure compliant and robust biologics processes.

You will work with cross-functional teams to advance new product launches while focusing on process robustness, product quality, and operational excellence.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field is required.
• 7+ years of engineering experience in manufacturing, process development, product development, or related field.
• Experience supporting regulated manufacturing environments.
• Experience with design for manufacturing (DFM), process capability studies, and MSA.
• Experience interpreting engineering drawings, GD&T.

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 based on specs and regulations; support installation and validation activities.
• Generate and review documentation including PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, and studies for product launches.
• Mentor engineers and deliver technical updates to stakeholders and leadership.

Skills

Technical leadership

Process development

Manufacturing readiness

Cross-functional collaboration

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

View the U.S. work location and transparency guide to find the pay range for your location. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.