BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Staff Product Development Engineer to work for a leading San Diego biotechnology company.
Sr. Staff Product Development Engineer
Looking for an experienced product development engineer with strong technical leadership credentials, to drive definition, design and manufacturing transfer of new disposable cartridge products, as part of a team responsible for development of integrated systems for genetic analysis.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Drive end-to-end product development from early concept through manufacturing transfer and new product launch
Define and develop requirements for disposable/consumable products, in conjunction with cross-disciplinary project teams that include Chemistry/Biochemistry, Mechanical/Electrical Engineering, Marketing, Commercial, Manufacturing and QA
Lead product and platform architecture and concept development for consumables/disposables, incorporating voice-of-customer, manufacturing, supply chain, chemistry, fluidics and engineering inputs.
Work side-by-side with applied research and technology development teams to evaluate and innovate new technologies and processes
Drive activities to demonstrate technical feasibility and define specifications
Drive manufacturing process selection, development and transfer
Manage vendors responsible for outsourced product and manufacturing tooling design
Work with Operations to define manufacturing strategy for new products
REQUIRED EDUCATION & EXPERIENCE:
B.S. in Mechanical Engineering, Bioengineering, Systems Engineering or related field (advanced degree preferred)
12+ years of product development experience within an R&D or new product development group, with close interfacing with manufacturing processes
Experience in the development of volume disposable devices and consumable products, including hands-on experience designing parts, assemblies and related manufacturing processes
Experience in project management of product development from conceptualization through manufacturing transfer
Highly collaborative and have good communication skills
PREFERRED EDUCATION & EXPERIENCE:
Masterâ€™s degree or PhD Mechanical Engineering, Bioengineering, Systems Engineering or related field preferred
Experience in applying a systems/holistic approach to product development, including requirements definition, analysis/modeling, architecture, integration and testing/validation
Experience applying critical parameter management to product development
Experience in a broad range of engineering disciplines
Experience in relevant manufacturing processes and statistical process controls
Experience in statistics and statistical analysis techniques
Experienced in leading or executing a structured development process
Excel in working across functional boundaries and building consensus among technical and non-technical stakeholders
Experience managing product design through outsourced design and manufacturing partners
Experience in developing products for a wide variety of processes, including injection molding, ultrasonic or laser welding, electronics soldering, leak testing, automated assembly and automated inspection.