The Senior Product/Process Development Scientist will play a pivotal role in advancing our mission to make healthcare more accessible and effective through innovative Point of Care (PoC) diagnostic solutions. This position is ideal for a driven scientist with a strong background in diagnostics or medical devices who thrives on optimizing processes, leading product enhancements, and collaborating across teams.
Key Responsibilities:
1. Process Analysis & Optimization: Conduct detailed evaluations of existing manufacturing processes to identify bottlenecks and areas for improvement. Develop and implement upgrades to enhance efficiency, reduce costs, and boost product quality.
2. Product Performance Enhancement: Assess current products for performance, quality, and user satisfaction, implementing strategic upgrades that align with user needs and regulatory standards.
3. Research & Development: Innovate and develop new methodologies or technologies for product and process improvement. You'll be at the forefront of R&D initiatives, bringing new ideas to enhance product functionality and scalability.
4. Data-Driven Decision Making: Collect, analyze, and interpret data to track performance metrics, support process improvements, and measure the impact of product changes.
5. Cross-Functional Collaboration: Collaborate closely with engineering, manufacturing, and quality assurance teams to implement and validate process changes. Ensure alignment of all improvements with company goals and customer needs.
6. Testing & Validation: Design and execute experiments for new processes and product modifications. Conduct validation studies to ensure modifications meet rigorous performance and compliance standards.
7. Documentation & Reporting: Maintain comprehensive records of research, methodologies, and findings. Prepare reports to communicate results and recommendations to stakeholders.
8. Training & Support: Support and train team members on new processes, methodologies, and product updates, fostering knowledge-sharing and smooth transitions.
9. Regulatory Compliance: Ensure that all process and product improvements comply with industry standards and regulations, including ISO 13485, IVDD, and IVDR.
10. Continuous Improvement Initiatives: Lead and participate in projects that promote ongoing improvement in product quality and process efficiency, contributing to a culture of innovation and growth.
Qualifications & Experience:
1. Educational Background: Degree in Chemistry, Life Sciences, or a related field. Knowledge of surface chemistry is a plus.
2. Industry Experience: 5+ years in manufacturing for diagnostics or medical devices, with a focus on PoC diagnostics or lateral flow devices.
3. Technical Expertise: Strong knowledge in microfluidics, immunoassays, and affinity/colorimetric sensing systems. Familiarity with handling biomolecules, such as proteins, antibodies, and metabolites.
4. Regulatory Knowledge: Proficiency with quality systems (ISO 13485) and understanding of in-vitro diagnostic regulations (IVDD, IVDR).
5. Tech Transfer: At least 3 years of experience in transferring technology from R&D to production, with a demonstrated ability to adapt laboratory processes for scalable manufacturing.
6. Soft Skills: Excellent communication skills, ability to work effectively within cross-functional teams, and a proactive, organized approach to problem-solving.
This role provides a unique opportunity to join a growing start-up at an exciting stage of development. If you're passionate about making a tangible impact in healthcare, let's discuss how your experience can help us reach new heights in diagnostic innovation.
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