Providesdirect and ongoing leadership for an organization of multiple individual contributors designing and developing engineering solutions for a microfluidic cartridge formolecular POCTor otherIVD Diagnostic products.

　　Closely collaborates and fosters collaboration of the teamwiththeinstrument,assayand system integration teamsas well as with the cartridge operationsteam.

　　Manages headcount, deliverables, schedules, and costs forthe cartridge developmentprograms, ensuring that resources are appropriatelyallocatedand that goals,objectives, timelines, and budgets are metin accordance withprogram and organizational roadmaps.

　　Works with Q&R to ensure compliancewithHP200A’sQMS, particularly making sure the team isproperly trainedand all equipment used for development is properlyclassified.

　　Engages withtheprogramhead, marketing, supply chain, technicalleadersand executives to communicate program status, escalate issues, and guides and influences strategic decision-making.

　　Proactivelyidentifiesopportunities for process improvement and cost reductions opportunitiesfor development spend as well as for cartridge COGS.

　　Providesoverall people-care management for direct reports, including hiring,settingandmonitoringof annual performance plans, coaching, and career development; drives and fosters organization-wide performance standards, expectations, and practices to support ongoing team member and process development.

　　Begins toprovidestrategic input to design, develop,optimize, qualify,validate, and transfer Medical Diagnostic Device Solutions (Instruments, Cartridges and Consumables).

　　Begins tobuild up Medical Device team and develop talentsand promote teamwork orientated initiatives and operational excellence.

　　May serve as an owner or contributor to corrective and preventive action (CAPA), Nonconformance, and Change Control

　　Providesinput into the development of changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.

　　Participates in compliance audits asrequired.

　　REQUIREMENTS:

　　Educational background:Amaster's orPhDInbioengineering, biomedical engineering, chemistry, or a related field. Equivalent industry experience may also be considered.

　　Experience:Minimum of 7 years of experience in cartridge development, with at least 3 years in a managerial or leadership role, ideally in the field of IVD POCT

　　Technical skills:Proficiencyin microfluidics, assay development, polymer science, and familiarity withIVDregulatory standards and requirements.

　　Leadership abilities:Proventrack recordof leading and developing high-performing teams, strong decision-making skills, and the ability to drive projects forward.

　　Communication skills:Excellent communication, presentation, and interpersonal skills, capable of effectively conveying technical concepts to both technical and non-technical stakeholders.

　　Problem-solving:Strong analytical and problem-solving skills, with the ability to innovate and adapt to changing project needs.

　　Adaptability:Comfortable working in a fast-paced, dynamic environment, able to prioritize tasks and manage multiple projects simultaneously.

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