Staff Engineer, Advanced Operations

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker is seeking a Staff Engineer to lead upstream and downstream biologics manufacturing process development and validation across internal and supplier operations. You will drive robustness, quality, and compliance while supporting new product introductions.

You will mentor engineers, define in-process controls, and prepare critical documentation to enable timely product launches in a regulated environment. This role emphasizes leadership and cross-functional collaboration.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• Minimum 7 years of engineering experience in manufacturing, process development, product development, or related field.
• Minimum 7 years of experience in regulated manufacturing environments.
• Experience developing and validating manufacturing processes, including statistical analysis and validation methodologies.
• Experience interpreting drawings, specifications, and GD&T.
• Experience with DFM, process capability studies, and MSA.

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 robustness and in-process controls.
• Evaluate, select, and qualify manufacturing equipment and components to meet technical specs and regulations; support installation and validation.
• Generate and review PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, and MSA documentation for product launches.
• Mentor engineers, provide technical guidance across portfolios, and deliver updates to stakeholders and leadership.

Skills

Process development

Manufacturing processes

Statistical analysis

Design for Manufacturing

MSA

GD&T understanding

Leadership / mentoring

Education

Bachelor's degree in Mechanical Engineering

Tools

PFMEA

Control Plans

SOPs

PPAPs

Validation protocols

MSA studies

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

• 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.