Senior Staff Engineer - Manufacturing Automation & Process Validation

Staff Engineer

Work Flexibility: Hybrid

What You Will Do-

• Provide technical leadership in designing, developing, and deploying automated solutions that minimize variability, streamline workflows, and enhance operational performance across multiple projects.

• Research advanced manufacturing technologies and develop new methods to automate production processes and digitally monitor performance for quality and efficiency.

• Collaborate with senior leadership to identify, develop, and execute opportunities for strategic and process improvements.

• Support capital equipment acquisition—including requirements definition, vendor evaluation, contract negotiation, installation, commissioning, and validation.

• Champion automation and manufacturing excellence across the site, including adoption of best practices and continuous improvement methodologies and Benchmark automation technologies and process capabilities across the Stryker network.

• Communicate effectively with business partners to resolve process, product, and equipment issues and evaluate project outcomes and provide manufacturing guidance, recommendations, and support as required.

• Support new product and new process introduction activities, ensuring alignment with Stryker’s New Product Development Process; conduct Gauge R&R studies, capability analyses, and process characterization for new and existing processes.

• Lead and execute process validations (VP, IQ, OQ, PQ), author associated documentation, and ensure compliance with regulatory expectations; value-stream and cross-functional projects, including scoping, budgeting, specification, execution, qualification, documentation, and operational handover.

• Demonstrate proficiency in applying industry standards, including design requirements, qualification strategies, and regulatory guidelines

• Lead creation, review, and refinement of engineering documentation including the Design History File (DHF), technical reports, and validation packages.

• Follow and mentor team members on R&D procedures, including design controls, risk management, and documentation per Stryker’s Quality Management System.

What you need-

Required Skills-

• Bachelor’s degree in Engineering—Mechanical or related field.

• Experience 8 years - 11 years

Preferred Skills-

• Strong ability to develop, optimize, and troubleshoot mechanical products, with strong understanding of DFM principles.

• Working knowledge of process validation, statistical tools (PFMEA, SPC), and methodologies including Lean, Six Sigma, and structured problem solving (DMAIC).

• Ability to communicate moderately complex technical concepts, project plans, and system architectures to cross-functional team members.

• Strong analytical skills; effective interpersonal skills and strong communications skill.

Travel Percentage: None

Experience Level

Senior Level