EDOM_益登科技股份有限公司

Project Planning & Execution: • Develop and manage project plans, timelines, milestones, and deliverables for R&D and product development initiatives. • Coordinate cross-functional teams to ensure smooth execution of project objectives. • Identify potential risks and develop mitigation strategies to keep projects on track. Stakeholder Management: • Act as the primary liaison between internal teams, external partners, regulatory bodies, and key stakeholders. • Facilitate communication and collaboration between scientists, engineers, and business professionals. • Provide regular project updates to senior management and investors. Regulatory & Compliance: • Ensure projects adhere to regulatory guidelines (e.g., FDA, CE-IVD, CLIA, CAP) and quality assurance standards. • Collaborate with regulatory teams to support submission processes and clinical validation studies. Budget & Resource Management: • Track project budgets, allocate resources effectively, and ensure cost-efficient operations. • Work with finance and leadership teams to optimize funding utilization for ongoing research and product development. Process Optimization & Scaling: • Implement best practices for project management and workflow optimization. • Support the transition from research to commercialization, including technology transfer and manufacturing scale-up.

Medical Affairs & Scientific Communication: • Serve as the primary medical and scientific expert on the company’s early cancer screening technology. • Develop and deliver scientific presentations to clinicians, researchers, and healthcare decision-makers. • Provide medical expertise for marketing and sales teams, ensuring accuracy in promotional materials. • Represent the company at scientific conferences, advisory boards, and industry events. Clinical Strategy & KOL Engagement: • Build and maintain strong relationships with key opinion leaders (KOLs), oncologists, pathologists, and researchers. • Collaborate with clinical and R&D teams to refine product development based on medical insights. • Facilitate investigator-initiated studies and clinical collaborations to generate real-world evidence. • Provide medical input into clinical trial designs and regulatory submissions. Regulatory & Compliance Support: • Ensure all medical affairs activities align with regulatory and ethical guidelines. • Assist in preparing clinical evidence for FDA, CE, and other regulatory submissions. • Stay up to date on industry trends, guidelines, and policy changes in molecular diagnostics and cancer screening. Training & Internal Collaboration: • Train internal teams (sales, marketing, and product teams) on the scientific and clinical aspects of our technology. • Work cross-functionally with product development, regulatory, and business teams to align medical strategy with company objectives.

Manufacturing & Production Oversight: • Lead the design, setup, and optimization of manufacturing workflows for LDTs. • Oversee the production of molecular diagnostic assays, ensuring reproducibility and high-throughput capability. • Develop and implement standard operating procedures (SOPs) for manufacturing. • Ensure scalability of production while maintaining efficiency and costeffectiveness. • Collaborate with R&D, Quality, and Regulatory teams to transition assays from development to full-scale production. Quality & Compliance: • Ensure adherence to Good Manufacturing Practices (GMP), CLIA, CAP, and FDA guidelines for LDTs. • Implement quality control (QC) and quality assurance (QA) measures for consistency and accuracy. • Maintain comprehensive documentation and records in accordance with regulatory requirements. • Conduct risk assessments and troubleshoot manufacturing challenges. • Drive continuous process improvement (CPI) initiatives to enhance product quality and efficiency. Team Leadership & Cross-Functional Collaboration: • Build and manage a manufacturing team, providing training and development opportunities. • Work closely with R&D, Regulatory, and Clinical teams to align production with product development goals. • Collaborate with supply chain and procurement teams to ensure timely availability of raw materials and reagents. • Support validation studies, process optimization, and technology transfer activities. Technology & Innovation: • Stay updated on emerging trends in molecular diagnostics manufacturing and incorporate best practices. • Evaluate and implement automation and process optimization strategies to increase throughput. • Drive cost-reduction strategies while maintaining product quality and regulatory compliance. QUALIFICATIONS & REQUIREMENTS: • Education: Bachelor’s, Master’s, or PhD in Molecular Biology, Biotechnology, Bioengineering, Biomedical Sciences, or a related field. • Experience: • 5+ years in manufacturing management within a biotech, molecular diagnostics, or life sciences company. • Experience in scaling up LDT manufacturing and transitioning from R&D to commercial production. • Strong understanding of molecular biology techniques (e.g., PCR, NGS, qPCR, ddPCR, etc.). • Familiarity with ISO 13485, CLIA, CAP, and FDA regulatory frameworks. • Knowledge of automation, high-throughput workflows, and process validation. • Skills: • Strong leadership, problem-solving, and communication skills. • Ability to work in a fast-paced, startup environment with agility and adaptability. • Experience with lean manufacturing, Six Sigma, and continuous improvement methodologies.

Technology Transfer & Process Development: • Lead the transfer of molecular assay technologies from R&D to manufacturing, ensuring scalability and reproducibility. • Develop, optimize, and validate processes for manufacturing, including reagent formulation, assay workflows, and automation strategies. • Collaborate with cross-functional teams, including R&D, quality, regulatory, and production, to ensure a smooth transition of technologies. • Implement best practices for process documentation, standard operating procedures (SOPs), and training materials. Regulatory & Quality Compliance: • Ensure transferred processes meet regulatory requirements (e.g., FDA, CLIA, CAP, ISO 13485). • Work closely with quality assurance and regulatory teams to support validation, risk assessments, and compliance audits. • Establish quality control (QC) measures and troubleshooting strategies for production. Collaboration & Project Management: • Act as the liaison between R&D, production, and external partners (CDMOs, suppliers) to ensure alignment on technical and operational needs. • Manage timelines, resources, and budgets for tech transfer projects. • Drive continuous process improvements and troubleshoot issues during scaleup and manufacturing.

We seek an innovative R&D Lead to drive the development of novel IVD assays for early cancer detection. This role requires expertise in NGS, qPCR, and biomarker validation, with a focus on translating research into clinically actionable diagnostics. The ideal candidate will lead cross-functional teams, oversee assay design and validation, and ensure compliance with regulatory standards.

1. 費用請款審核作業 2. 會計帳務月結作業 3. 提供員工財會相關作業流程諮詢，協助作業順利 4. 公開資訊申報與ESG相關事宜窗口 5. 其他主管交辦事項。

HW FAE工程師 1. 協助業務推廣產品與產品應用說明 2. HW 線路設計Review 與Debug問題解決支援 3. 客戶專案進度追蹤 4. 英語基本溝通能力

1. 固定資產管理(含採購管理、變更管理、修繕保養管理)等 2. 總務行政庶務作業，如辦公室環境巡檢、清潔維護、費用請款、請購採購驗收作業 3. 緊急應變管理 4. 公司活動辦理或協助，如尾牙、開工、祭祀相關活動 5. ESG相關專案執行 6. 其他主管交辦事項

1. 定期拜訪客戶，維繫穩定客戶關係; 研究市場趨勢，熟IC市場，解決客戶問題 2. 掌握客戶產品進度，進行商品推廣並提供客戶服務 3. 客戶進銷存處理，依照客戶提供的需求快速且確實回覆交期，了解追蹤客戶的生產進度和數量，並進行合理的庫存管理 4. 積極參與團隊合作並實現共同目標

1. 協助PM進行MRP物料分析，並執行採購作業流程 2. 與國內外供應商(原廠)協調相關事宜及異常處理 3. 安排進貨流程與物料追蹤 4. 製作相關報表及費用請款

1. 收集及建立勞工安全衛生作業計畫。 2. 執行公司內、外部安全衛生業務。 3. 處理突發之勞工安全衛生事宜。 4. 執行安全衛生教育訓練。

1. 負責集團海內外HR工作管理 (HR full function) 2. 協助組織運作，負責勞資會議、人評會、支援福委會會議、舉辦公司內部活動等 3. 處理公司ISO 9001:2015、ESG等作業流程。 4. HR對內外溝通窗口&其他主管交辦事項

1. Assist product line technical support and development; 2. Performs duties well, supports team decision, and achieves common goals

1. Provide the latest information on product specifications and applications in the market as a reference for customers when designing products; 2. Assist product line technical support and business promotion; 3. Understand the customer industry, industry competition and market conditions by interacting with customers; 4. Actively understand customer needs and respond quickly; 5. Performs duties well, supports team decision, and achieves common goals

• Weekly management of the Customer backorder report. • Work and assist the Sales team in managing their Customer pre & post shipment. • Support and drive the requirements generated by Customer Bond Constraint Report related to fulfillment of bonded parts in their BIM program.(If applicable) • Manage customer’s portal update and customized report if required. • Update customer production change requirement within Future System to optimize inventory planning.

1.孰悉國內主要EMS廠, 並具備管理業務團隊經驗 2.具備半導體產品業務銷售經驗 3.定期拜訪客戶，加強既有客戶或建立新的客戶關係。 4.掌握客戶產品專案進度，適時進行產品推廣並提供客戶服務。 5.進行產品報價及產品展示，並處理帳款回收相關事宜。 6.管控客戶訂單以及產品庫存。 7.其他主管交辦事項