Staff Engineer — Biologics Process Development & NPI

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

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.