Staff Engineer (Cleaning, Labeling, Packaging &… at Stryker · Suzhou

Staff Engineer (Cleaning, Labeling, Packaging & Sterilization) Location: Suzhou, China Work Flexibility: Hybrid or Onsite Position Summary The Cleaning, Labeling, Packaging & Sterilization staff Role is an exciting opportunity to become a SMEs and to be the Point of Contact for the (XXXX) Site. The role will have contacts across a global network and will ensure that the processes can be validated and optimized while supporting NPI’s from other locations. The SME Role includes: Ownership and development of the Cleaning, Labeling, Packaging & Sterilization Technical Competency and Technology Roadmap for the XXXX site. Identifying and introducing new technologies and processes that enable product roadmap and improve cost and time to market (CTM and TTM). Serve as the subject matter expert (SME) in Cleaning, Labeling, Packaging & Sterilization. Develop, maintain, and improve CPLS standards, procedures, and work instructions. Pioneering incremental and step change continuous improvement initiatives, that facilitate NPI to be faster, future-fit and differentiated. Aligns with the business on digital programs and drives relevant initiatives within TECS. Technical Responsibilities (Short Business Version) A. Cleaning (Pre‑Sterilization Manufacturing Cleaning) Define and validate cleaning processes (IQ/OQ/PQ), including residue, endotoxin, and bioburden limits in line with ISO 19227, ISO 11737, and ISO 10993‑18. Specify and qualify cleaning chemistries, equipment, and cleanliness acceptance criteria. Lead risk management activities (ISO 14971), including CAPA and audit support. Ensure appropriate cleanroom classification and controls per ISO 14644. Maintain cleaning validation documentation, trend analyses, and risk files. B. Labeling Ensure compliance with FDA 21 CFR 801, EU MDR Annex I (Section 23), and ISO 15223‑1. Establish and validate label data flows (UDI, LOT/EXP), barcode systems, print verification, e‑IFU (where permitted), and translation/artwork processes. Manage label control procedures, UDI assignment, system IQ/OQ/PQ, and change‑control documentation. C. Sterile Packaging (SBS Design & Validation) Lead sterile barrier system validation according to ISO 11607‑2. Define and execute integrity and performance testing (ASTM F88, F1929, F2096). Select and justify packaging materials (e.g., Tyvek, films, trays), including microbial barrier rationale, aging, and distribution claims. Oversee IQ/OQ/PQ of sealing and thermoforming processes. D. Sterilization (Modality Selection, Validation & Control) Own the definition, validation, and routine control of sterilization processes to SAL 10⁻⁶. Maintain sterilization validation plans, PQ documentation, release criteria, requalification cycles, and supplier oversight. Manage EO (ISO 11135), radiation (ISO 11137‑1:2025), and VH₂O₂ (ISO 22441) modalities, including requalification and residuals per ISO 10993‑7. Lead supporting microbiology activities (ISO 11737) and ensure cleanroom readiness (ISO 14644). Minimum Qualifications (Required): B.S in Mechanical Engineering or related discipline with 4+ years of experience in at least 2 of the 4 processes. Excellent command of written and spoken English Experience with quality management systems (ISO 9001, AS9100, ISO/IEC 17025). Excellent analytical, organizational, and communication skills. Proficient in Microsoft Office tools Familiarity with statistical process control (SPC) and measurement system analysis (MSA). Experience with automation and digitalization Proven track record overseeing the introduction of new technology from early identification through the release of an application for serial manufacturing. Lean 6 Sigma qualification such as Green Belt would be benefitial. Travel Percentage: 10%