Senior Director / VP, Product Development
San Francisco Metro Area, California
- This person leads the product development and execution of the company s end-to-end (sample-to-answer) instrument. This position is responsible for managing the product development staff while also serving as the lead interfacing between the company and its external design and development partners and providers.
- This person will work closely with other functional areas to translate customer requirements into appropriate product requirements and development plans; oversee quality management of the system hardware, software, firmware, assay and related aspects of its consumable products; coordinate projects in their scope, schedule, resources and budget; establish Design Control adherence during development; lead system integration activities; support the validation activities and eventual launch of the platform.
- Experience with hardware, software and assay development life cycles, creating design inputs and outputs, design verification and design validation.
- Strong technical knowledge and hands-on experience with the tools and methods used in system development and assay development are essential.
- This individual must possess excellent communication, analytical and problem-solving skills while being adept at forming collaborative working relationships with internal and external team members.
- Focus areas are within nucleic acid biomarkers.
- Quality management and design control for all system engineering of the company s products
- Plan and coordinate the creation of comprehensive hardware and software requirements, assay requirements and functional specifications that feed into the design and development of the system
- Build current and future competitive advantage by understanding and addressing the needs and opportunities of our markets and customers
- Build and lead a team that works collaboratively across a matrix organization to execute the portfolio, leveraging resources and support from R&D, marketing and sales
- Represent the company and build relationships with engineering companies, manufacturing third parties and eventually distribution partners
- Plan and coordinate the execution of appropriate design verification/validation testing
- Play a strong role in development and maintenance of Quality System elements, specifically for Design Control.
- Establish risk analysis activities which include the use of risk analysis tools and mitigation procedures
- Share a passion for our mission to improve human health by democratizing access to state of the art molecular diagnostics
- 8+ years experience leading a diverse, experienced team developing life science or IVD systems following applicable regulatory guidelines
- A background of senior leadership positions with organizations that have demonstrated significant growth in size and complexity
- Demonstrated experience in taking conceptual research through development to a viable IVD platform for commercialization
- Been there, done that experience for IVD product development from early stage development (innovation stage) to late stage development (product validation) required
- Strong negotiation skills
- Excellent program/project management skills including scheduling, budgeting, resource management, etc.
- Experience in microfluidics is strongly preferred
- Graduate degree (MS or PhD) in Engineering/Science, or related field