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:
- 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.
- Product Performance Enhancement: Assess current products for performance, quality, and user satisfaction, implementing strategic upgrades that align with user needs and regulatory standards.
- 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.
- Data-Driven Decision Making: Collect, analyze, and interpret data to track performance metrics, support process improvements, and measure the impact of product changes.
- 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.
- Testing & Validation: Design and execute experiments for new processes and product modifications. Conduct validation studies to ensure modifications meet rigorous performance and compliance standards.
- Documentation & Reporting: Maintain comprehensive records of research, methodologies, and findings. Prepare reports to communicate results and recommendations to stakeholders.
- Training & Support: Support and train team members on new processes, methodologies, and product updates, fostering knowledge-sharing and smooth transitions.
- Regulatory Compliance: Ensure that all process and product improvements comply with industry standards and regulations, including ISO 13485, IVDD, and IVDR.
- 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:
- Educational Background: Degree in Chemistry, Life Sciences, or a related field. Knowledge of surface chemistry is a plus.
- Industry Experience: 5+ years in manufacturing for diagnostics or medical devices, with a focus on PoC diagnostics or lateral flow devices.
- Technical Expertise: Strong knowledge in microfluidics, immunoassays, and affinity/colorimetric sensing systems. Familiarity with handling biomolecules, such as proteins, antibodies, and metabolites.
- Regulatory Knowledge: Proficiency with quality systems (ISO 13485) and understanding of in-vitro diagnostic regulations (IVDD, IVDR).
- 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.
- 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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