Work Flexibility: Hybrid What you will do: Support new product and process introductions in accordance with Product Development Process (PDP), Design Controls, and Quality System requirements. Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations teams to industrialize and transfer new products into manufacturing. Participate in manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up . Should have strong understanding of the difference between verification and validation. Develop, execute, and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Traceability Matrices, and Final Reports. Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment, processes, tooling, fixtures, and production systems. Support Master Validation Planning and validation lifecycle management activities. Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements. What you will need: Required
Qualifications
Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline. Minimum 6+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or a related discipline within medical devices, pharmaceuticals, biotechnology, or other regulated industries. Hands-on experience executing IQ/OQ/PQ protocols for equipment, processes, tooling, fixtures, and manufacturing systems.
Experience
with reviewing test requirements derived from product requirements Validation and End-of-Line (EOL) Tester qualification and validation. Working knowledge of Computer System Validation (CSV) methodologies and regulatory expectations. Strong understanding of GMP, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 60601, and risk management principles. Preferred Qualification:
Experience
with PFMEA, Control Plans, PPAP, and process qualification methodologies. Working knowledge of MSA, Gage R&R, process capability analysis, and statistical tools such as Minitab.
Experience
supporting New Product Development (NPD), design transfer, and manufacturing scale-up activities. Strong problem-solving, project management, and technical documentation skills. Excellent communication skills and ability to collaborate effectively across multidisciplinary global teams. Travel Percentage: 20% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.