Senior Design Engineer Fluxion Biosciences

Summary:
Fluxion Biosciences is a rapidly-growing bioanalytical tool company which is addressing critical needs inthe clinical research, pharmaceutical, biotech, and life science research markets. We are looking forindividuals who will thrive in a fast-paced environment and contribute to the development andcommercialization of our line of products for cellular analysis.

Fluxion is currently looking for a senior design engineer responsible for the mechanical and systemsdesign, testing, and transfer to manufacturing of bioanalytical systems. The successful candidate will be asenior individual contributor, as well as provide strategic and tactical direction for engineering anddevelopment across multiple product lines. The scope of responsibility will bridge the continuum fromproduct concept through design phases, pilot manufacturing and ultimate release to manufacturing. Thisindividual will design and develop new, provide support to manufacturing process development, and leadengineering efforts to lower manufacturing costs of existing products. .The successful candidate will be a key member of the development team and will report to the CTO.Fluxion offers a competitive compensation package, excellent benefits, and stock options.

The Senior Design Engineer will:
? Design cell handling instrumentation and sub-components for new products to ensureperformance and scalability, with a focus on mechanical design? Provide design support for microfluidic consumables, including tooling
? Design and implement testing plans for the proposed systems, and provide data-driven decisionmaking for key design alternatives in areas of high risk
? Ensure scalable product development with the focus on cost-effective design andmanufacturability? Implement successful engineering practices for product development projects that will ensurecompliance with required quality standards
? Engage vendors and consultants as appropriate, including prototyping, manufacturing supportservices, outside design services, and regulatory testing groups
? Support any modification of current products needed to reduce field failure and new features toenable successful adoption by targeted markets
? Troubleshoot instrument performance issues for both existing products and prototypes
? Support manufacturing operations on a as-needed basis to increase product quality and decrease labor requirements

Profile and Requirements
? Excellent 3D CAD design skills (SolidWorks preferred)
? M.S. in mechanical engineering, or equivalent experience
? 10+ years of experience in the area of hardware/mechanical design, a working knowledge ofelectrical systems and software development, and demonstrated product development skills
? Experience with all aspects of the product development cycle, including pilot production of precommercialunits and transfer to manufacturing
? Previous experience in the life science tools industry is highly desired
? Project management expertise (bringing products to market on time and on budget), assessingand addressing key risk areas, and setting timelines with a high degree of urgency and accuracyhighly desired? Knowledge in the areas of document control and quality engineering systems
? Experience with regulatory requirements (ie ISO 9000 and/or IVD regulations) highly desired
? Experience with outsourcing aspects of development and manufacturing to domestic and offshorelocations would be ideal
? Strategic thinker who understands customer needs, along with market and technology trends, tomaintain the company's

Location:	South San Francisco, CA United States