HP is the world’s leading personal systems and printing company. We create technology that makes life better for everyone, everywhere. Our innovation springs from a team of individuals, each collaborating and contributing their own perspectives, knowledge, and experience to advance the way the world works and lives.

At HP 200A (named after Hewlett-Packard’s first product – the HP200A audio oscillator), we are driving the strategic direction for our new, microfluidics-based, growth businesses… beginning with healthcare diagnostics. As the world’s largest microfluidics company with 30+ years of inkjet printing experience, we have the expertise and scale to craft sophisticated microfluidics solutions that can disrupt healthcare diagnostics.

Description

We are seeking a highly motivated and qualified candidate to join our strategic effort and lead a biochemistry & assay development team responsible for researching, developing and integrating molecular diagnostic assays into novel & disruptive diagnostic platforms

Responsibilities

• Grow, establish, and manage a team of talented scientists and engineers responsible for developing and integrating IVD molecular diagnostic assays into our sophisticated devices and platforms. Manage those activities through all phases of product development.
• Oversee experimental designs, data analyses, and development documentation. Support issue investigations and root cause analyses as needed for the projects.
• Leverage your subject matter expertise and experience to provide scientific/technical leadership and management of the assay development projects including development of user needs, design requirements, specifications development, QC methods, verification, and validation studies.
• Transfer new designs to manufacturing and ensure on-time regulatory submissions.
• Set development timelines and prioritize efforts to deliver on commitments.
• Collaborate with senior technologists and other functional leaders to participate in the creation of future strategic technical roadmaps and lead their execution.
• Follow and improved our development processes and implement best practices for design and development for manufacturability and usability.
• Be the technical guide and mentor for the team to create a high performing team with superior capabilities.
• Support continuous improvements activities pertaining to manufacturing processes, lab operations & infrastructure.
• Build and maintain strong partnerships with product design, manufacturing, QA/regulatory, etc. Maintain a customer and solutions focus with diverse functional stakeholders.
• Ensure compliance with internal procedures, FDA 21 CFR Part 820, ISO 13485:2016 and other applicable regulations.
• Identify and facilitate external collaborations as needed in partnership with technologists.

Education & Experience

• Masters or PhD in biology, biochemistry, molecular biology or related field.
• 10+ years industry experience in a diagnostic, medical device or life science technology
• 5+ years industry experience in molecular diagnostic development
• Subject matter expert with hands-on experience in molecular diagnostic methods and expertise in technologies including NAT & qPCR.
• Familiarity with diagnostic methods for infectious diseases.
• Experience with developing and commercializing IVD products in regulated markets
• Prior experience developing POC and cartridge-based products desirable.
• Experience with the process of obtaining IVD-CE and FDA clearance/approval of IVD products, preferably in molecular diagnostics.
• Demonstrated success in building and growing strong technical teams.
• Commitment to people management, talent development, and culture shaping.
• Excellent technical writing, verbal communication, and organizational skills.
• Demonstrated project management skills including time and risk management, resource prioritization, and project structuring

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