【About Company】
SHL Medical is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018.

【Job Overview】
The Risk Analysis Engineer of Process Design is responsible for supporting new process development, automation equipment development and product transfer through the application of Quality engineering skills for medical devices. This person will handle projects and deliver risks analysis, from product/process inception through product launch, scale-up, deployment, retrofit, change management, and play an active role in the processes to ensure products meet quality standards consistent with Customer Requirement, while meeting all process control, risk mitigation and control, and other regulatory requirements, including, but not limited to FDA Quality System Regulation 21 CFR Part 820, 21 CFR Part11, ISO 13485, ISO 11608 & ISO 14971.

【Main Responsibilities】
• Represents Quality Engineering in Risk Analysis field on process design, equipment development, and product transfer projects through Process Development Lifecycle.
• Ensures that all design control and process/production control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements.
• Assesses failure modes and approves the risk mitigation tool, techniques, good practices, and formal document to ensure the Risk Management processes are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – DFMEA, PFMEA, and other risk assessment in system level.
• Participate in relevant Post-Process Development Lifecycle activities to provide/collect information and ensure risk identification, risk mitigation, and risk control are well managed and consistent through FMEA and RMF – e.g. Customer Complaint, NCMR, Change Management, Deviation Meeting etc.
• Lead cross-functional meetings with project team members to communicate and manage all open items from FMEA reports and derive solution to mitigate and control the risks, including actively engage with internal AMSD and external vendor/supplier where needed.
• Supports Device process development, equipment development, and product transfer activities, including the following:
- Consolidates or reviews lessons learned and historical data to influence product design.
- Supports or reviews process/equipment specifications and requirements including system level.
- Supports or reviews process/equipment engineering study and verifications activity (protocols and reports).
- Participates in product or process/equipment design and change activities, including qualification and reviews.
- Participates in risk analysis activities including review failure mode effects analysis (FMEA) and/or risk or statistical analysis.
- Provides suggestion of risk identification, mitigation, and control for product and process quality attributes/decisions.
- Support selected qualification activities (e.g., advanced inspection performance check, sterilization validation, etc.) with external suppliers.
• Contributes to compilation and maintenance of Design History Files (DHF) and Risk Management File (RMF).
• Ensures proper design and development, and Risk Management documentation as per ISO 13485/ISO 14971 FDA QSR Quality System.

【Required Skills & Qualifications】
Education:
• Technical / scientific degree at college / university level (mechanical, industrial, biomedical, chemical, system, material engineering and engineering management).

Experience:
- Occupational experience
• At least 3 years of work experience in a New Process Development, Design Assurance, Advanced Equipment/System Qualification function in a regulated environment (medical devices/Diagnostic instrumentation industry, pharmaceutical, biotechnology industry, or similar high-volume precision manufacturing industry).
• Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, metallic fastener, with integrated/non-integrated testing, and in-process inspection by vision system.
• Experience in the design and development of products/processes in accordance with ISO 13485 and ISO 14971 guidelines.
• Experience in the entire Design Lifecycle and Phase-Gate development process.
• Experience in Measurement System Analysis (MSA) and Gauge Repeatability and Reproducibility (GR&R).
• Experience in GAMP5 V model and verification/validation activities such as FAT/SAT and IQ/OQ/PQ.
• In-depth know-how and experience of quality techniques is a plus: Six Sigma Blackbelt, Six Sigma methods, Quality Function Deployment (QFD) such as DFSS, DMAIC, DoE, control chart etc.
• Strong communication, analytical, and problem-solving skills.

- Special knowledge, expertise, experience
• cGxP Know-How including regulations ISO 13485, ISO 14971:2019, FDA 21 CFR 820, FDA 21 CFR Part11, MDD 93/42/EEC.
• GAMP5 Know-How including verification (FAT/SAT) and validation (IQ/OQ/PQ).
• Statistical methods and analysis is a plus like DoE, SPC, Acceptance Sampling, Process Capability Analysis etc.
• Statistical tools is a plus such as Minitab or JMP etc.
• SAP, PLM (Teamcenter), ALM (Polarion) will be an advantage.
• English (spoken and written), local language (Mandarin) is a plus.